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1. in specific cases such conformity may not be limited to the essential requirements Symbolizes that the person affixing the CE marking has verified that the product conforms to all the Community provisions and has been subjected to the appropriate evaluation procedures Where products are subject to other directives the CE marking must indicate that the prod ucts are also presumed to conform to the provisions of those other directives The CE marking must consist of the initials CE taking the appropriate form and must have a height of at least 5 mm The CE marking must be affixed to the product or its data plate however when this is not possible or not warranted it must then be affixed to packaging and to the accompanying documents Any product covered by the directives must bear the CE marking except where specific direc tives provide otherwise The CE marking shall be affixed at the end of the production control phase When a notified body is required and involved in the assessment i e type exam the CE marking must be followed by the identification number of the notified body The affixing of any other marking liable to deceive third parties as to the meaning of the CE marking is prohibited A product may bear different marks for example marks indicating conformity to national or European standards provided such marks are not liable to cause confusion with the CE marking The CE marking must be affixed by t
2. FIGURE 5 1 The Risks of Non Conformity 80 CE MARKING HANDBOOK Example 2 Product Safety Enforcement in Finland Product safety experts can usually spot noncompliant products visually in a matter of seconds or minutes without removing a product s cover Minor discrepan cies found on the outside of the equipment often mean that bigger problems are within For example over a two year period the Finnish enforcement authority obtained over 1 200 products from stores and importers for market surveillance pur poses The inspectors selected products that appeared to have external deviations such as wrong nameplate incorrect plug or cord user manual missing or unknown trademark The results of the audit testing were as follows e 24 had minor deviations from the standards 76 with CE marking 44 had deviations that may endanger safety 66 with CE marking 8 had serious deviations 57 with CE marking and only 24 met the relevant safety standards 65 with CE marking Over 75 of the 1 200 products tested failed to meet the requirements Depending on the audit findings the resulting actions taken by the Finnish author ity varied from written warnings to product withdrawals or a total ban on sales It is common knowledge among the EU notified bodies and enforcement authorities that minor deviations seen externally on the equipment such as wrong informa tion on nameplate incorrect indicator
3. Where are you now M check one or more boxes O Denial and Isolation O Anger and Rage O Bargaining O Depression O All of the above eel affix CE marking FIGURE 7 1 Self Test Checklist Total Harmonization and Product Certification Meeting the European Conformity safety testing and design requirements for CE marking is as simple as one two three 1 components 2 construction and 3 testing A product s compliance with the European requirements relies on the application of good common sense experience and knowledge of the European safety philosophy and standards Of utmost importance is consumer protection via conformity to the harmonized standards The standards and directives were not established to get in our way but to help us to comply with one common set of rules a total harmonization that builds consumer confidence in what we do gt European and international standards EN and IEC are fast becoming the de facto worldwide requirements for product safety EMC quality and the environment 138 CE MARKING HANDBOOK The manufacturer is responsible for designing equipment in accordance with the essential requirements and the harmonized standards You should have a general understanding of the directives for enforcement and procedural issues but focus on the standards for product design and conformity assessment When a product conforms to the standards we
4. highest creditability and acceptance by both customers and authorities Doing anything less may be a waste of money and time Just because a notified body appears in the Official Journal does not mean the customer must accept it Even the European Commission recognizes that there are over 10 000 testing laborato ries and 1 000 certification bodies in Europe of varying capacity legal status and reputation v The credibility and reputation of the bodies issuing Approval Marks are more important than ever before Figures 4 3 4 4 and 4 5 illustrate examples of approval mark certificates issued by European bodies Notified Bodies and Certification 61 Fachausschu amp Verwaltung Priif und Zertifizierungsstelle im BG PRUFZERT Hauptverband der gewerblichen Berufsgenossenschaften Translation GS Test Certificate no of certificate Name and address of the holder of the cartificate COMPUTER COMPANY customer ASICS WALK SILICON VALLEY Name and address of the manufacturer COMPUTER COMPANY ASICS WALK SILICON VALLEY Ref of customer Ref of Test and Certification Body Date of Issue 7 1994 Q27192 na N2 1aag Product designation Personal Computer Visual display unit MONITOR ABC Keyboard KEYB 123 gt System unit CPU 333 Type Tower ABCD 1234 ee Intended purpose Testing based oh Principles for occupational sale testing of electronic data cee a gt equipment and visual display units rele
5. The following definitions are set down for the purpose of this directive e National authority responsible for monitoring the market means the national authority designated by the member state and required by it to check the conformity of product placed on the Community or national mar ket with the applicable Community or national legislation Directives and Procedures 27 e Accompanying document is any document that must accompany a product when it is placed on the market in accordance with the legislation e Marking is any marking or labeling that products must bear in accordance with the legislation and that certifies that the product conforms with that legislation and e Customs authority shall mean the authorities responsible for the applica tion of customs legislation If the national authorities find that a product presents a serious and immediate risk they shall prohibit the product from being placed on the market and ask the cus toms authorities to include the following endorsement on the commercial invoice accompanying the product and any other relevant document Dangerous product release for free circulation not authorized Regulation EEC No 339 93 Where national authorities determine that the product does not conform with the Community or national rules on product safety they shall take the appropriate measures which may if necessary include prohibiting the product from being placed on the market and shall als
6. allow limited fire during testing In stark contrast the EU safety standards and experts pay special attention to shock hazards through separation of circuits components isolation transformers and PCBs to keep the high voltages isolated from the operator Additional construc tion requirements and tests are also employed for short circuits single faults pro tection of the service personnel guarding and so on LU Obtaining European standards is the easy part understanding the requirements is another story Misapplication and or misinterpreta tion are commonplace Applying U S standards or safety methodology to product assessment increases the risks of nonconformity because there are fundamental technical and interpretation differences between the U S and EU views ANSI UL vs EN IEC In the area of safety philosophy the U S test agencies known as Nationally Rec ognized Test Laboratory s NRTL stress fire and tests whereas the European bodies focus on shock and construction Both camps generally consider all safety 72 CE MARKING HANDBOOK aspects during a product assessment but because of the major philosophical and technical differences between the U S and EU there are oftentimes different test results or findings Because of these fundamental differences in the concept of safety products designed to meet only the U S standards rarely meet the European requirements Meeting the European standards a
7. location construction component types and placement and grounding and ingress protection IP For most machines enclosures must provide a minimum protection of IP 54 which means protection against dust and splashing water Figures 6 6 and 6 7 The first digit refers to the dust rating and the second to the water If an X is signified in the rating it means that the test was not performed i e IP X4 says it was water tested only IP 54 is the minimum degree of protection for most machine enclosures with a higher or lower degree allowed depending on the installation conditions or environment In addition to the IP rating other construction requirements exist All openings including those in the bottom or those for mounting purposes shall be closed in a manner ensur ing the specified degree of ingress protection Components and devices may not be placed on doors except those for operating indicating Don t forget that the door must have a ground wire or strap since the hinges are not considered ade quate for grounding purposes Enclosure doors should have vertical hinges lift off type and captive fasteners In general if the enclosure bears an EU type approval mark it may be considered to comply with the IP and construction requirements without further testing Also enclosure manufacturers whose prod uct lines are EU type approved usually offer complimentary products with EU approvals such as air conditioners lights power strips
8. t rely on test results to be the stimulus for the safe design of the product consider safety before addressing other design elements RA Design and build a product to meet the standards Enclosures and tests box it and pot it are never substitutes for a safe design and should not cover for noncompliant components or improper construction A product s conformity to the European safety standards relies on the use of proper component and construction principles Testing is performed after a sound design is in place The Hierarchy of Conformity Checks 1 Check for components with European Approval Marks as positive evi dence of compliance CE not considered 2 Evaluate the products construction according to the relevant standards 3 Perform all relevant tests after components and construction are in order BA In only rare cases should safety testing come first If testing is performed prior to component and construction assessment and defi ciencies are discovered safety and or EMC retesting may be necessary Principles of Safety To meet the relevant safety standards and manufacture safe products it is essential that designers understand the principles of safety The following is not an alternative to the detailed requirements of the standards but is intended to provide designers with an appreciation of the principles on which these requirements are 86 CE MARKING HANDBOOK based The requirements of safe
9. 73 23 EEC 1 1 1997 Electromagnetic compatibility EMC 12 31 1995 Machines 89 392 EEC 12 31 1994 Simple pressure vessels 87 404 EEC 7 1 1992 Pressure equipment 5 29 2002 Equipment for use in explosive atmospheres 94 9 EC 6 30 2003 Active implantable medical devices AIMD 90 385 EEC 12 31 1994 Medical devices general MDD 93 42 EEC 6 15 1998 Medical devices in vitro diagnostics IVD 7 1 2002 Telecommunications terminal equipment and 98 13 EEC 11 6 1992 or satellite earth station equipment 5 1 1995 Non automatic weighing machines 90 384 EEC 1 1 1993 Gas appliances 90 396 EEC 12 31 1995 Household appliances energy efficiency 96 S7 EC 3 9 1999 88 378 EEC 1 1 1990 Recreation craft small boats Construction products Personal protective equipment Passenger lifts 95 16 EC Explosives 93 15 EEC 1 1 2003 Directive reference numbers ending with EC were issued after 1993 Directive 98 13 EC replaced 91 263 EEC and 93 97 EEC FIGURE 2 1 List of EC Directives for CE Marking Generic directives type B Generic directives address a specific range or group of products such as products operating between certain voltage lim its under the Low Voltage Directive LVD or products that may generate RF emissions EMC These directives cover the unregulated sector of products Typical unregulated products are information technology equip ment ITE or household appliances
10. Most prominent among the generic directives are the Low Voltage and EMC directives Note In the case of EMC where no standards exist or are not applied in full involvement of a EU competent body may be required prior to CE marking Directives and Procedures 17 Product specific directives type C Product specific directives apply to regulated products such as telecom and medical as well as other prod ucts where extreme hazards exist such as machinery listed in Annex IV of 89 392EEC Involvement of a EU body may be mandatory but not in all cases If the class or type of product is regulated by the directive then a European body must assess it and issue a Type Exam Certificate prior to CE marking Product specific directives cover machinery pressure vessels medical products telecom devices toys and others It is neces sary to refer to the relevant directive to see whether the involvement of a EU notified body is mandatory for the product or machine in question Type C directives take precedence over types A and B directives and refer to them as needed I focus on three primary directives types B and C that relate to electrical products and machinery as well as some of the basic directives type A Most elec trical products and machinery fall under two primary directives and several basic directives The three primary directives are The Low Voltage Directive LVD 73 23 EEC The LVD is an electrical safety direct
11. Opening a hinged door by hand without a tool makes the area behind the door an operator access area and all hazards shall be adequately guarded or the door interlocked to remove hazards before access A tool is reserved for service personnel and defined as any object that can be used to operate a screw latch or similar fixing means Service personnel have training and experience and should be aware of poten tial hazards while performing a task and can take measures to minimize the danger to themselves and others Service personnel have access to maintenance areas and will be reasonably careful in dealing with the obvious hazards The product s design how ever should protect service personnel from any possible mishap by using shields for hazardous voltages segregation of SELV from hazardous voltages warning labels and interlocks A design should protect service personnel from unexpected hazards such as accidental or inadvertent touching of live electrical components and other haz ardous parts during servicing The service access area is an area other than the oper ator access area that service personnel can access even with the equipment power on Safety interlocks common to machinery provide a means either of preventing operator access to a hazardous area until the hazard is removed or of automatically removing the hazardous condition i e electric shock moving parts when access is gained Safety interlocks have special requireme
12. on product is visible to custom ers for increased marketing and sales potential Approval is viewed as a Quality Marking by Marks issued by European consumers notified and competent bodies e Mark verifies compliance of all products in The Approval Mark is backed series by an official test report and cer tificate from a European accred ited body OJEC Note In Europe notified and competent bodies have higher status than CB NCBs see CB Scheme below e Tests per EN standards and IEC standards e Official certificate and test report TRF e Technical file documentation complete and accurate e May support manufacturer s CE marking e National enforcement authorities may consider marks with report as defense of due diligence Advantages a e Official test report TRF Tests per EN standards and IEC standards e Authorities may consider report Official i Test Same as above except no e No factory inspection fee certificate or mark Disadvantages Report Report limited to product s tested per S N e No Approval Mark or Certificate for potential customers and national enforcement authorities e May only address specific standard s The CB Scheme is a mutual recognition of test results scheme for safety of electrical products The CB Scheme is intended to facilitate certification or approval at a national l
13. with regard to cooperation in action taken to avoid risks L The safeguard clause included in the primary directives allows the total ban of nonconforming products and possible fines and or imprisonment of the responsible person Finally CE Marking Amendment 93 68 EEC reiterates the theme where a Member State authority establishes that a CE marking has been affixed unduly the manufacturer agent shall be obliged to make the product comply as regards to the provisions concerning the CE marking and to end the infringement under conditions imposed by the Member State Where non compliance continues the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure its withdrawal from the market 22 CE MARKING HANDBOOK Note This section focuses on key elements of the directive and is only a part Refer to the directives for the complete text The actual wording of the directives is binding Product Liability Victims Rights Prior to the New Approach directives should a manufacturer find itself in court the manufacturer need only show that reasonable measures were taken to ensure a safe product In 1985 the Product Liability Directive was issued changing the old focus of negligence to that of strict liability on the manufacturer s or supplier s part thereby shifting the onus better to protect the consumer and placing a greater burden
14. 103 10 Insulation and Separation of Circuits 105 11 Grounding 106 12 Power Disconnect 107 13 Circuit and Thermal Protection 107 14 Stability and Mechanical Hazards 108 15 Warnings Instructions and Languages 110 16 Flammability of Materials 111 17 Electrical Safety Testing 112 18 Production Tests 114 19 Additional Requirements for Machinery 115 Protective Measures 116 Mains Disconnect Switches 116 Emergency Stop Switches 117 Fault Tolerant Components and Safety Circuits 117 Transformers 118 Motors 118 Wiring 119 Protective Earth 120 Access Areas 120 Enclosures 121 Contents ix Functional Markings 121 Item Designation 123 Warning Symbols 127 Manuals 127 Technical Documentation 128 Safety Checklist 129 OZErK Chapter 7 Conclusion 135 Focus on Standards 135 CE s Credibility at Risk 135 Self Test Where Are You Now 136 Total Harmonization and Product Certification 137 Appendix A European Safety and EMC Acronyms 143 Appendix B Information Sources 145 Index 147 This Page Intentionally Left Blank Preface Welcome to CE Marking Handbook A Practical Approach to Global Safety Certification If you are a manufacturer or exporter of products bound for the European market you might have assumed that shipping products to Europe was a rather simple operation but found yourself confused by the complex maze of European Conformity laws and regulations If you are a consumer
15. 52 basic 47 48 defined 138 essential requirements 49 52 European 42 44 focus on 135 generic 47 48 harmonized 3 4 41 46 harmonized standards presumption of conformity 41 46 product specific 47 48 selecting 46 48 state of the art 49 52 valid for conformity assessment 45 versus directives for conformity 11 13 State of the art 49 52 Strength test electric 114 15 Strict liability 22 77 Subassembly defined 124 Substitution testing 72 Supervision and procedures 69 Supplementary insulation 86 Supplier defined 22 Surveillance market 76 77 of products 55 56 Sweden machine safety enforcement in 80 81 Switches E stop emergency stop 117 mains disconnect 116 17 Symbols 87 warning 127 T TC technical committees 41 TCF technical construction file 32 33 defined 5 Technical documentation 128 33 Technical files 31 32 defined 5 139 Technical rules 41 52 Terminal blocks 104 Terminal designations defined 125 Terminals 103 Test reports 32 67 defined 5 140 Testing 56 57 and certification bodies 55 electrical safety 112 14 flammability and 12 production 72 substitution 72 U S safety 74 Tests electric strength 114 15 and enclosures 85 and fire 71 72 flaming oil 71 ground continuity 115 production 114 15 type 113 Thermal protection 107 8 Third parties 3 53 56 Third party marks 81 Transformers safety and isolating 118 Tunnel vision 46 47 Type and m
16. FIGURE 3 2 European Commission View on Standards for Safety Conformity Standards The Technical Rules 51 FIGURE 3 2 continued The Global Approach to Certification and Testing Commission Communication 89 C 267 03 The Council resolution of 7 May 1985 showed the way by accepting that there could be more than one means of proof of conformity to a directive It provided for presump tion of conformity to a directive on the basis of a European harmonized standard or during a transition period of national standards which had been submitted and recog nized as equivalent under Community control procedures Guide to the Implementation of Community Harmonization Directives The concept of harmonized standards plays a important role in the framework of the New Approach Directives in which it has a specific significance Conformity with national standards that have transposed harmonized standards whose references have been published by the Commission in the Official Journal of the Euro pean Communities confers a presumption of conformity with the essential require ments of the New Approach Directives Manufacturers are responsible for ensuring that the products they place on the market meet all relevant regulations harmonized standards etc e Ifa product bearing the CE marking is found not to conform with the essential require ments laid down by the directives or if the standard
17. Guidelines for Use of Conformity Assessment Procedures Ltd The aim of the CE marking is to symbolize the conformity of a product imposed by the directives and to indicate that the manufac turer supplier has undergone all the evaluation procedures laid down by Community law The CE marking is used to facilitate controls on the market by inspectors Directives and Procedures 29 The procedures for conformity assessment are chosen from the various mod ules and in accordance with the criteria set out in the primary directives Departure from the procedures is allowed only when the specific circumstances of a directive so warrant Quality is shown in some of the modules but a common mistake for some ISO 9000 quality certified companies is to assume that they can select a mod ule that utilizes ISO 9000 when this is not possible unless the primary directive allows it There is no mention of ISO 9000 quality in the LVD EMC and Machin ery directives see Product Quality versus Factory Quality in Chapter 5 ISO 9000 quality may be necessary for some products i e medical products under the Medi cal Device Directive MDD ta ISO 9000 Quality is for companies and factories it does not cover product safety or EMC conformity For most products and machines the self declaration process module A is possible In practice the manufacturer performs the complete product assessment according to EU standards issues the declaration and
18. Other than the exempt items all materials and components shall pass a flammability test or have a flam mability rating such as Class V 0 or 5V V 1 V 2 HB or for foamed materials HF 1 HF 2 HBF Class V O and 5V are equivalent and the best ratings V O and 5V are self extinguishing within five seconds and flaming drops or particles do not ignite surgical cotton V 1 may take up to 25 seconds to extinguish and flam ing particles may not ignite the cotton so V I is a lower rating than V 0 or SV Class V 2 self extinguishes within 25 seconds however the flaming particles may ignite the cotton Some of the common plastic materials and their minimum flammability classi fications are e Class V 1 Fire enclosures for movable equipment not exceeding 18 kg e Class 5V Fire enclosures of movable and stationary equipment exceeding 18 kg e Class V 2 Printed circuit boards V 1 preferred see Exempt e Class V 2 Wiring harnesses e Class V 2 HF 2 Air filter assemblies possible exceptions e Class HB Decorative parts mechanical and electrical enclosures and parts of such enclosures if located external to fire enclosures e Exempt Components meeting flammability requirements of relevant IEC component standard certain wire insulation PVC TFE PTFE FEP Neoprene small parts mounted on V 1 material I Cs transistors opto couplers capacitors etc one or more layers of insulation adhesive tape etc individual clamps heat resista
19. The United States and European Union place a different emphasis on safety hazards Fire hazards are the most important safety consideration in the United States and shock hazards are of the highest priority in Europe Fire statistics between two comparable size U S and EU cities show a interesting trend with five to ten times more incidents of fires in U S cities The underlying reason for this is the difference in voltage and current e g the mains power supplied to products For example the power in the United States is about 115 volts for portable products with double the input current i e 6 amps whereas in Europe the voltage is double that of the United States about 230 volts with half the current i e 3 amps Hence with the higher voltage in Europe there is an increased risk of shock EU 230 V vs U S 115 V With double the current in the United States the risk is primarily fire U S 6 A vs EU 3 A High voltage in Europe gt Shock hazard High current in United States wir hazard Quality and Enforcement 71 GY The requirements contained in the standards and the safety experts interpretations reflect wide differences of opinion between U S and EU views toward safety You must look at the history of UL s fire enclosures and plastics flammability rating system to understand the U S view Historically the North American stan dards and agencies UL CSA focused on flammability
20. The term product is preferred by this author and will have the same meaning as 4 CE MARKING HANDBOOK equipment e g product appliance or machine and may include components in the general sense Components are devices that are built into equipment cannot function alone and rely on the end product for their safety Review the following definitions as these will be the basis of our discussion Official Journal of the European Communities OJEC This is Europe s regis ter of legislation directives information and notices lists of standards and notified bodies Perhaps the most singularly important document for European Conformity the Official Journal as it is often called is where the directives and standards are published making them valid for use by product manufacturers and accepted by national authorities Amendments to the directives and standards are included in the OJEC as well as listings of the accredited testing and certification bodies The OJEC is published and revised on a regular basis Directives are the European laws published in the Official Journal that give us the essential health and safety requirements EHSRs that shall be followed by prod uct suppliers These are commonly called the Essential Requirements ERs The directives deal with legal and procedural issues such as assessment procedures cer tification implementation enforcement technical files declarations CE marking and other basic concepts Exa
21. achieve a presumption of conformity to the essential requirements of the directives The end product manufacturer is accountable for all conformity aspects for their products including the design components documentation declaration and CE marking If the equipment becomes suspect or there is an incident shifting the blame to others such as a consultant test lab or component supplier is not possible Making sound deci sions such as sourcing EU type approved components and obtaining certifica tion on the end product may not at first seem to be the most convenient path but in the end it is the easiest and lowest cost alternative Putting consumer safety first helps to limit the suppliers risks as well as to achieve your main goal of pro tecting the customer consumer user operator Figure 7 2 shows the steps to European conformity Let s review a few important European Conformity definitions e Directives Directives are European laws that detail the legal procedural and CE marking requirements for products Directives are published in the Official Journal and describe in general terms the essential health and safety requirements that must be met to allow products to be placed on the market and ensure the free movement of goods The directives also mandate the publication of safety and EMC standards that equipment man ufacturers must follow to obtain the presumption of conformity e Standards Europe
22. affixes the CE marking to the product A technical file or documentation must also be available on demand for national enforcement authorities Keep in mind that this is an internal self assessment process a do it yourself approach that results in issuance of the manufacturer s declaration of conformity and the CE marking Figure 2 6 The buyer may demand proof of safety EMC compliance in the form of a mark certificate or test report from a European notified or competent body All products covered by the directives must be assessed for conformity and bear the CE marking prior to entry into the European Union The quantity of prod ucts or machines or the nature of the transfer does not relieve the manufacturer from performing the conformity assessment and from affixing the CE marking This applies to all products and machines put into service in a public or private capacity for professional or nonprofessional use and for payment or free of charge In cer tain circumstances such as trade shows products may be allowed into the European Union for a limited time with the proper warnings on the product Such units may be operated only by the manufacturer The essential objective of a conformity assessment procedure is to enable the authorities to ensure that products placed on the market conform to the requirements expressed in the directives and these products must meet the high level of safety that the directives seek for a g
23. and procedures 15 39 border controls 26 27 CE marking guidelines 33 39 conformity assessment procedures 27 31 customs authorities 26 27 declaration of conformity 33 documentation 31 European laws 15 18 modules 27 31 product liability and victims rights 22 26 product safety protection and safeguards 18 22 technical files 31 32 test reports 32 Product Liability 21 26 77 Product specific 17 Disconnect power 107 Documentation technical 128 33 Double fixing 87 Double improbability defined 103 Due diligence defense of 3 57 63 defined 57 Duly substantiated request 31 E E stop emergency stop switches 117 Earth protective 120 EEA European Economic Area 37 EEC European Economic Community 8 EHSRs essential health and safety requirements 4 Electric shock defined 86 Electric strength test 114 15 Electrical safety 84 for products and machines 83 85 testing 112 14 EMC electromagnetic compatibility 1 5 11 acronyms 143 44 compliance 2 directives 16 17 enforcement in Europe 78 79 Emergency measures 20 Enclosures 121 edges and corners of 109 openings in 110 and tests 85 Energy hazards 86 Enforcement 65 82 authorities 42 EMC enforcement in Europe 78 79 machine safety enforcement in Sweden 80 81 product safety enforcement in Finland 80 ENs European Norms 4 11 12 34 42 44 54 137 Index 149 Equipment classification 98 99 defined 3 84 mobili
24. but do not affect the lia bility of the manufacturer Testing certification and inspection activities place the emphasis on preventing as far as possible the putting on the market of unsafe products thus avoiding damage being caused OJEC 89 C 267 03 European notified bodies safety and competent bodies EMC are accredited at the national level by the member states such as in Germany at the European level accreditation occurs when notified to the Commission and listed in the Official Jour nal of the European Communities These accredited bodies are sanctioned by the European Commission and the member states to interpret directives and standards and issue test reports and certificates on conformity When a product becomes sus pect or an incident occurs the national enforcement authority may consider a test report or certificate issued by a European body Having the notified body mark cer tificate and test report usually shifts the onus of proof in the manufacturer s favor since the product was evaluated and certified by European recognized experts RA A certificate is a visible form of attestation through an indepen dent and impartial third party Certification means that a product or ser vice conforms to certain technical rules contained in standards or regulations An approval mark and certificate visibly demonstrate product quality safety EMC and can lay to rest any doubts the consumer may have concerning a produc
25. by a notified body is required After successful testing a Type Exam Certificate for machinery or Certificate of Conformity for EMC is issued by the EU Body The manufacturer then affixes the CE marking and issues a declaration of conformity Note In all three cases the CE marking declaration and technical file shall be in place ISO 9000 factory quality techniques are not a part of modules A Aa or B C see Product Quality versus Factory Quality in Chapter 5 The relevant safety EMC directives and conformity assessment modules still apply Technical Files Documentation and Test Reports With Europe s new American style liability laws preventing accidents through the proper use of warnings and design documentation gains more impor tance The number and size of liability claims against producers distributors and importers are increasing The manufacturer must be able to prove that it considered all relevant safety EMC aspects and supplied a product without defects Because a no fault defense is no longer viable the manufacturer s ability to prove that the product was not defective at the time it was put into circulation gains even more significance Simply showing that a certain model or serial number was manufac tured is not enough The product suppliers must be able to prove through their documentation that adequate design production and quality control procedures were in place to ensure a compliant product that is
26. by double reinforced insulation two to three layers of insulation Reinforced insulation is required between hazardous voltages and SELV and is comprised of basic and supplementary insulation Supplementary is an independent insulation applied in addition to basic e g two levels of protection Energy hazards may exist from the outputs of high current power supplies Injury may result in burns or molten metal by short circuits between adjacent poles such as by metal or ring on finger bridging the supply outputs The hazard may still exist even in low voltage circuits where the current is high Two levels of protection shall be provided such as by insulation grounding shielding or safety interlocks Operators must be protected from shock and energy hazards exceeding these limits 42 4 V peak 8 amps 240 VA and 20 joules energy Operators are all the persons who use the product excepting service personnel Safety requirements assume that operators do not mean to create a hazardous situation and are oblivious to electrical and other hazards You also must assume that the opera tor does not normally possess tools reserved for service personnel and maintenance purposes Equipment must protect janitors and casual visitors as well as operators An Design Guide for Safety Conformity 87 operator access area is any area that under normal operating conditions allows access without the aid of a tool for example by a person s hand or fingers alone
27. certified for compliance with the relevant standard as above shall be checked for correct application and use in accordance with its specified rating It shall be subjected to the applicable tests of this standard as part of the equip ment and to the applicable tests of the component standard under the conditions occur ring in the equipment Note The applicable test for compliance with a component standard is in general car ried out separately The number of test samples is in general the same as that required in the component standard 1 5 2 EN 61010 1 IEC 1010 1 Safety of Test and Measurement Devices in Lab Use kens Where safety is involved components shall comply with the applicable safety require ments specified in relevant IEC standards If components are marked with their operating characteristics the conditions under which they are used in the equipment shall be in accordance with these markings unless a specific exception is made 14 1 EN 60335 IEC 335 Safety of Electronic Products for Household and Similar Use e Components shall comply with safety requirements specified in the relevant IEC stan dards as far as they reasonably apply 24 1 EN 60204 1 IEC 204 1 Safety of Machinery Electrical Equipment of Machines Electrical components and devices shall be suitable for their intended use e g industrial heavy light commercial leisure domestic and shall comply with the rel
28. critical components fulfill a specific safety function when in use and the failure or malfunctioning of the device places exposed persons in imminent danger Safety components are regu lated by the Machinery Directive and examples include light curtains two hand controls and sensor mats Under the Low Voltage Directive LVD the CE marking is affixed primarily to finished products that 1 are ready to use and 2 can operate Examples include electrical equipment appliances apparatus and systems that are intended for the final user and placed on the market as a single commercial unit Compo nents designed for use within built in products or machines must comply with component safety standards to satisfy the General Product Safety and Product Liability Directives but do not require CE marking because they have no autono mous use e g they do not operate within the specified voltage range and are not ready to use v Notice Components to be incorporated into equipment where their safety depends to a very large extent on how they are integrated into the final product or machine cannot be CE marked Examples of components that do not require CE marking are electromechani cal components relays microswitches connectors active components transistors diodes opto s ICs and passive components capacitors coils resistors The European Commission s Guidelines on the Application for the Low Voltage Directiv
29. current and frequency The label must also indicate the manufacturer s name and type number model number and should be located adja cent to the inlet or power entry Additional information such as serial numbers date codes and approval marks may be on the same label The label should be on the exterior of the product and easily recognizable by the user for portable equip ment or by the installer for larger equipment If the rating label is located behind an operator accessible door not recommended for example within ITE a visible temporary marking should also be used Do not use the words voltage amps hertz or others when IEC symbols exist Use proper European symbols whenever possi ble such as V for voltage A for current and Hz for hertz A dash is used to indicate a range 220 240 Vac and a slash for either or 120 230 Vac If the equipment utilizes only two wires for input line and neutral as a dou ble insulated product and there is no ground connection it is then necessary to mark the product with the Class II symbol Examples of rating labels for single phase products are XYZ Corp XYZ Corp XYZ Corp Model No 1234 Model No 1235 Model No 1236 115 230 Vac 230V 5A 50 60 Hz 220 240 Vac 3 A 50 60 Hz 2 0 A 50 Hz Using AC is optional for ITE The symbol may be used instead of AC Examples of rating labels for three phase equipment are ABC Machine Inc ABC Machin
30. equivalent to evaluate a product s lack of conformity Going against the directives authorities and consumer expectations see Product Liability in Chapter 2 may place the product s manufacturer in a hopeless situation if the product s conformity is questioned When European standards ENs exist always use them to ensure confor mity with the European directives In some cases European alternatives e g EU national standards may be considered but must be justified Use of other so called non European alternatives such as U S standards and others may be indefensible in court and could actually place the product and manufacturer in a position of nonconformity Standards versus Directives for Conformity Europe s directives laws describe the Essential Health and Safety Require ments that suppliers must meet before equipment is placed on the market The direc tives tell us what must be done from a procedural and legal point of view such as the CE marking the declaration the technical file enforcement or design concepts Standards on the other hand give detailed safety requirements that tell us exactly how safety and EMC may be accomplished in the field of engineering and design such as guarding warnings components electrical testing or pass fail criteria Var ious machine safety concepts and documentation requirements are also discussed in the Machinery Directive but they are presented for the most part in general term
31. for Safety Conformity 133 Product Model No Serial No Directive s Standard s 19 Clause Requirements Comments Additional machine requirements complies with 15 items in Safety Guide A O Machine safety standard EN 292 1 2 614 1 954 1050 EN 60204 1 Other applicable standards Refer to electrical and machine safety standards technical docu mentation and reports attached Lohbeck Notes on using the Design Checklist CE marking and declarations of conformity should not be considered as evidence of compliance for components products or machines v P Pass F Fail N Not Applicable placed in right column Identify clause s from the applicable standard s and place in second column More than one standard or clause may apply Comments should include how and why the product passed failed P F or explain why the clause is not applicable N Attach Constructional Data Form CDF test results and other support documenta tion to the Safety Checklist Notice The Safety Checklist is for a preliminary safety review only and does not take the place of a complete assessment or test report s Other requirements may apply Refer to appropriate standards and directives for final assessment and completion of test report s This Page Intentionally Left Blank CHAPTER 7 Conclusion We can forgive a child who is afraid of the dark the real trag
32. for sale hire leasing or any form of distribution in the course of his business shall be deemed a producer and shall be responsible as a producer and where the producer of the product cannot be identified each supplier of the product shall be treated as its producer unless he informs the injured person within a reasonable period of time of the identity of the producer or of the person who supplied him with the product The same shall apply in the case of the imported product if this product does not indicate the identity of the importer referred to above even if the name of the product is indicated Damage means damage caused by death or personal injuries and damage to or destruction of any item of property other than the defective product itself with a lower threshold of 500 ECU provided that the item of property i is of a type ordinarily intended for private use or consump tion and ii was used by the injured person mainly for his own private use or consumption Defective product is when a product does not provide the safety which a per son is entitled to expect taking all circumstances into account including the presentation of the product the use to which it could reasonably be expected that the product would be put and the time when the product was put into circulation FIGURE 2 3 Product Liability Terms 6 The Law now allows consumers to initiate civil actions indepen dent of the auth
33. for three phase The old voltages of 220 to 240 Vac or 380 415 Vac may still apply in some countries Please note that 208 Vac common in the United States is not generally available in Europe For ITE take the measure ments at the desired frequency 50 Hz and at 10 for a singular voltage rating 230 Vac or 6 to 10 for a voltage range 220 to 240 Vac Because input cur rent varies at the extremes of the test range it may reduce testing if the rated volt age shown on nameplate is limited since all testing will be performed at 10 or 6 to 10 of the rating value see product standard for test ranges For example if a computer is rated at 200 to 240 Vac the safety tests would be per formed at 6 to 10 of the rating shown on the label testing range of 180 to 254 Vac A printer with a single rating of 230 Vac would require 10 of 230 V fora test range of 207 to 254 Vac After taking the input measurements select an input rating for the label slightly higher than the measured value such as measured 2 75 A label marking 3 0 A Do not select an input for the label that is well above the measured value because all product testing would then be performed at that value by adding loads and so on The products operating input power may not exceed 110 of the rating shown on the label 100 CE MARKING HANDBOOK 6 Rating Label Products shall be provided with a input rating marking label or plate to specify the input voltage
34. in conformity with essen tial requirements safety objectives of the directive without applying harmonized international or national standards In such a case the product will not benefit from presumption of conformity conferred by the use of such standards and the manufac turer must include in the technical documentation see Chapter 5 a description of the solutions adopted to satisfy the safety aspects of the directive continued 52 CE MARKING HANDBOOK FIGURE 3 2 continued Guide to the Application of 89 336 EEC Relating to Electromagnetic Compatibility EMC e European Harmonized Standards play a key role not just because they significantly simplify the conformity assessment procedures Article 10 1 of the directive if used in full but also because they provide by consent a unique harmonized technical solution that has been based on an EMC analysis This means that even if those standards are not used they are voluntary in the design and manufacture of the apparatus manufac turers should take them into account when performing their analysis e The EMC directive is a new approach directive laying down apparatus protection requirements and leaving it to standards primarily harmonized standards to define product characteristics By way of information Annex 7 contains a list of harmonized European standards that have been published in the EC s Official Journal The application of the ap
35. in order of preference a reject component and select alternative or b test component if pass document or c if EU type approval exists on simi lar components within same series expert reviews test report and sample component for acceptance rejection one reject or test D Evidence not available 1 No positive evidence available e g no EU approval mark or third party report Product manufacturer rejects component or performs complete testing according to the relevant standard s Testing by EU third party expert preferred Fail Note The component manufacturers declaration or CE marking if present should not be used to ver ify conformity Lower ratings indicate a increased risk of non conformity or potential failure when tested If the component in question falls within ratings C or D the component and test report should be assessed by a European safety expert prior to its acceptance In the case of testing non approved components in the end product and if successful test results are achieved the end product manufac turer takes on the conformity responsibility of the component and guarantees its on going compliance Lohbeck FIGURE 6 2 Component Acceptance Criteria Evidence of Compliance Design Guide for Safety Conformity 95 These are not approvals from independent third parties even when marked on the component CE IEC VDE IEC 947 VDE 0660 to name ju
36. introduction of the CE marking Some laboratories boast of their affiliations or partnerships with EU notified and competent bodies displaying certifications that attest to their indisputable qualifications and imply that their work is backed by EU partners Certain U S laboratories have gone as far as purchasing some of the smaller EU notified bodies in hopes of gaining access to both European conformity work and the manufacturer s pocketbook However external laboratory testing is supported by the EU body only if the body directs the lab s work and issues a certif icate and or test report for the products testing Also beware of consultants who confuse you by selling their affiliations on one hand and telling you don t really need the EU body certificate on the other If you use a consultant seek out one with expertise who provides sound reasonable advise and confirms such by obtaining both a certificate and mark from a European notified or competent body This is the best protection for the consumer and you WA y Selling affiliations over certifications increases risks to the manu facturers and consumers EU bodies may subcontract certain testing activities to private laboratories The rules concerning subcontracting of work by notified bodies to outside laborato ries are strictly limited to specific tasks and stipulate that the notified body itself Quality and Enforcement 69 must perform the assessment
37. is used And machine manufacturers must supply user manuals in that language As specified in the standards suitable warnings and symbols shall be provided for hazards but warnings shall not take the place of a safe design Protection of the operator from all possible hazards must be ensured by two levels of protection protection of ser vice personnel against unexpected hazards is achieved with one level of protec tion 88 CE MARKING HANDBOOK Design Guidance I have attempted to simplify the concepts so that technicians engineers and other professionals in the industry can understand and apply them I have numbered the design tips and topics for easy cross reference to the Safety Checklist at the end of this section Remember that there is no substitute for experience and proper train ing and that the design tips presented here do not take the place of the standards The design tips and subjects discussed are CSCr 7NMW PWN e e e e e oe oe omer TIA nM fPWNK OO Component Safety and Liability Component Selection and Conformity Verification Constructional Data Forms CDF Equipment Classification Power Consumption Rating Label Markings and Indicators The Single Fault Concept Input Wiring Terminations and Identification Insulation and Separation of Circuits Grounding Power Disconnect Circuit and Thermal Protection Stability and Mechanical Hazards Warnings Inst
38. law of the Member State in whose territory the product is in cir culation OJEC 92 59 EEC art 4 Standards are valid for conformity assessment after 1 publication in the Offi cial Journal as a harmonized standard and 2 transposition into national standards As an example some of the official national versions of the ENs for Safety of Infor mation Technology Equipment ITE are e German version DIN EN 60950 EN 60950 IEC 950 e British version BS EN 60950 EN 60950 IJEC 950 e French version NF EN 60950 EN60950 IEC 950 The harmonized standards are listed appended to the directives themselves The proper European standard must be applied for conformity assessment as fol lows in the following order of preference 1 A European harmonized standard EN referenced in the Official Journal 2 When no harmonized standard EN exists an IEC standard published in the relevant directive 3 When no harmonized standard EN or IEC exists a European National Standard i e DIN VBG BS in force in the member state 4 In absence of standards mentioned above Community specifications member state standards codes of practice in the sector concerned or to the state of the art and technology to the safety which the EU consumer may reasonably expect 46 CE MARKING HANDBOOK In the last two cases it is advisable and sometimes mandatory to consult a notified body for guidance and testing Authorities are obliged to recognize that
39. member states the necessary tools for surveillance and enforcement but implementation is left to the national authorities Most important uniform market surveillance is established to achieve a high level of safety protection for all citizens and build consumer con fidence in the products they buy Trust is good but effective control is better We must recognize that manufacturers sometimes make mistakes Some EU countries only check for the CE marking and declaration of conformity at the border which does not ensure a product s conformity more than 50 of products with CE mark ing fail to meet safety and EMC standards If EU consumers cannot trust products from abroad they will continue to buy those manufactured locally Safety should not stop at the border 1 and 2 below with only documentation checks Market sur veillance will only work if enforced by local safety EMC experts on the ground via product audits and testing 3 and 4 below Quality and Enforcement 77 The surveillance levels follow with higher numbers indicating increased sur veillance effectiveness Surveillance at the border by customs inspectors and authorities 1 Administrative Check for CE marking and declaration etc 2 Product Brief review of labels accompanying documentation etc Surveillance on the ground by authorities with support of safety EMC experts 3 Administrative Detailed review of declaration CE marking manual
40. plastics wire insulation and enclosures Emanating from this evolved the theory that during fault tests an internal fire is permitted within the product just as long as it eventually goes out fire shall not propagate beyond equipment assuming the product is constructed of flame retardant materials and has a fire enclosure To exemplify this concept the enclo sure bottom openings in computers and similar products are restricted to a maxi mum diameter of 2 mm 0 08 in to limit the spread of fire With this concept it is assumed that dripping flaming plastic will self extinguish prior to exiting through the bottom openings If the openings exceed the size limits then the product is sub jected to UL s infamous flaming oil test whereupon flaming oil is poured through the interior of the product and onto an awaiting test cotton below If the cotton ignites the product fails the test Therein lies the fallacy the cotton usually ignites thus forcing the product to be redesigned with small openings facts are stranger than fic tion The North American concept of allowing a limited burn within a product is unacceptable to many EU testing bodies and is therefore not allowed Instead EU standards require a fuse or other protective device to activate to prevent any fire and not merely contain it as U S philosophy allows as European safety theory says fire is not permitted U S stan dards impose fire enclosure requirements and
41. process ended up more confused than when they started There is an abundance of myths surrounding the CE symbol and its value The value of the CE marking for selling products has been overstated and the risks of nonconformity have not been well understood and that accounts for much of the confusion The CE marking is only the product manufacturer s symbol of self declaration it indicates a product s conformity to the minimum requirements of the applicable directives Although the CE marking does permit a product s access to the EU it is not an approval mark certification or quality mark nor should it be a marketing tool The CE marking is limited in scope While enabling products to be placed on the European market it allows for the free movement of goods and Preface xiii permits the withdrawal of nonconforming products but no more There is no such thing as a CE approval or CE certification In reality the CE marking is not an approval mark or certification but is actually an unqualified mark since it is only the manufacturer saying I did it trust me Professionals and seasoned consum ers familiar with products bearing only the CE marking sometimes refer to it as the mark of nonconformity because of their negative experiences with nonapproved products and components bearing this marking The CE marking should not be confused with other approval marks or certifications issued by an EU accredited certification body A
42. products manufactured in conformity with harmonized standards are presumed to conform to the essential requirements of the directives LH Over 5 000 EN 5 000 IEC and 10 000 ISO standards have been issued so far Of the 5 000 EN standards issued over 600 have been published in the OJEC as of this writing with many more to come Since most ENs are based on IEC stan dards compliance with the EN standards also ensures conformity with equivalent IEC standards The world is following Europe s lead and most countries have or eventually will have accepted the European standards or the IEC equivalents Therefore meeting the European standards will also help manufacturers to comply with the technical standards worldwide Selecting Standards Compliance with the EN standards is the minimum acceptable criterion for conformity so lH start by identifying the appropriate standards also see Essential Requirements The science of selecting the appropriate standards can be simple or complicated depending on your experience and product type Exercise care when identifying the proper standards that may apply to your product design The selection of a product standard may be a relatively simple task as for many Low Voltage Direc tive LVD products or cumbersome as for some machines You must consider the product s intended usage and make sure the product falls within the standard s scope Ba The regulations demand the proper choice and applic
43. recommend listing the components in order starting from the input inlet or cord and working your way through the product s circuit diagram Components at line voltage 120 230 400 Vac and at hazardous voltage or energy levels gt 50 Vac 60 Vdc must be listed and controlled Components below these lim its are not usually listed unless they have a safety function such as a door interlock or safety switch operating at any voltage Components below the safe voltage limits with moving parts or made of hazardous materials such as DC fans disk drives and batteries should however be listed Do not list any components that are not safety relevant such as I Cs and most components in SELV circuits Plastics used in the construction of a product must meet the relevant flamma bility ratings such as V 2 for PCBs and V 1 for enclosures In this case a plastic that has been tested and rated by a North American agency UL CSA according to the relevant flammability requirements of the standards may be acceptable Consult an EU testing body for their acceptance and documentation criteria see Figure 6 4 for CDF and Figure 6 3 for critical components examples 4 Equipment Classification The electric shock classification of the equipment will determine the extent of insulation needed to protect users and service personnel Insulation is safer than fusing Insulation is achieved by separating circuits and is required for example between user
44. representative of the forms to the requirements of the results of testing the assembled standard equipment The European bodies especially in Germany issue certified approvals and marks according to clearly defined standards which are definitive statements on their assessment results The European approval term means that the equipment bearing an approval mark has been successfully tested and passed but more impor tant approvals are perceived by users and customers as a guarantee that the equip ment is safe for use see Notified Bodies and Certification in Chapter 4 It is not just using the correct standard that counts more important it is proper interpretation Customers users and authorities have the right to question Who did the assessment self test or EU third party notified body and Does the prod uct really comply To answer these questions and allay customer s fears many companies have their products tested in the U S by an outside lab NRTL or con sultant in accordance to an international standard i e UL 1950 IEC 950 Some 74 CE MARKING HANDBOOK companies feel that this U S testing is a substitute for European conformity testing by EU third parties but this could not be further from the truth Other companies wisely take the sound approach and limit their risks by submitting products to noti fied bodies The European labs have much experience assessing products that have already been tested an
45. require replacement several times over the life of the equipment For cord replacement the strain relief must allow for a wide range of cord sizes and stay with the equipment during the replacement U S type strain reliefs typically do not meet IEC requirements IEC style strain reliefs are typically plastic not metal with ferules blocks for cord compression Input wiring terminals must be properly marked such as for protective earth PE neutral N and line s L depending on the power distribution system and standard applied QNL PENL PE N LI L2 13 N L1 L2 L3 The proper wire colors and approval markings must be used for fixed power cords The fixed power cord should have a lt HAR gt mark to ensure it meets the IEC standards for wire size insulation and colors e g brown for line blue for neutral Design Guide for Safety Conformity 105 and green yellow for protective earth PE Do not use green yellow for purposes other than safety ground Do not use for SELV ELV low voltage returns or EMC RFI grounds Also light blue signifies the neutral conductor In general for some products covered by the Low Voltage Directive wires can be any color with green yellow reserved for safety grounds You should however follow the accepted color conventions throughout When dressing the fixed input cord wires make sure to pro vide an adequate service loop for the PE wire so it would be the last to break if the strain relie
46. show conformity European harmonized standards ENs offer the simplest means of meeting the essential health and safety requirements EHSRs of the directives Standards The Technical Rules 45 The Commission Act on the Global Approach states The Council resolution of 7 May 1985 showed the way by accepting that there could be more than one means of proof of conformity to a directive It provided for presumption of conformity to a directive on the basis of a European harmonized standard or during a transition period of national standards which have submitted and recognized as equiva lent under Community control procedure When the manufacturer com plies with these standards the directives allow him to make use of simplified certification mechanisms When the product does not con form to a standard however either because the standards do not exist or because the manufacturer for in the case of innovation prefers to apply other manufacturing criteria of his own choice the assessment of con formity to the essential requirements must may involve a third party either by certification or by third party testing via notified competent body OJEC 89 C267 03 Furthermore the General Product Safety Directive states Where there are no specific Community provisions i e European har monized standards governing the safety of the products in question a product shail be deemed safe when it conforms to the specific rules of national
47. such as products for use in heavy industrial areas The generic EMC standards list performance criteria and refer to type A standards for tests Some examples of type B standards are EN 50082 1 2 immunity requirements for Residential Commercial Light Industrial Areas 1 and Heavy Industrial Areas 2 Product standards type C Type C standards address a specific product or related group or range of equipment The type C standards take precedence over the basics and generics and call up the appropriate A and B standards when neces sary The type C nomenclature varies slightly between the directives with the term product specific standard being the most widely recognized for type C s e Low Voltage Directive product specific standard e Machinery Directive machine safety standard e Electromagnetic Compatibility Directive product family or specific standard There are numerous product standards For electrical LVD products EN 60950 Safety of ITE EN 61010 1 Safety of Measurement and Lab Devices EN 60335 Safety of Household and Similar Appliances For machinery EN 415 Safety of Packaging Machines EN 201 Safety of Plastics Molding Machines EN 1010 Safety of Paper Machines For EMC Product Family Standards examples are EN 55011 Emissions for Industrial Scientific and Medical Products EN 55022 Emissions for Information Technology Equipment EN 55014 Emissions for Household Appliances and EN 55104 Immunity for
48. that this defect came into being afterward or e That the product was neither manufactured by them for sale or any form of distribution or e That the defect was due to compliance with mandatory regulations issued by public authorities or Directives and Procedures 25 Criteria from plaintiff Conditions of evidence Germany cl 823 of BGB Fault Liability Evidence of damage Product fault Cause of damage and product defect EC Directive 85 374 EEC Liability Evidence of damage Product fault Cause of damage and product defect Liability Bodily damage Property damage Pain and suffering Bodily damage Damage to privately owned property Maybe pain and suffering Amount Unlimited Unlimited possibly up to 80 million EURO Liability time limit 30 years after product is first marketed 10 years after product is marketed Cause of liability of defective product Liability chain Design fault Fabrication fault Instruction fault Negligence during production monitoring Manufacturer of end product Component and material manufacturer Importer of technical equipment As part of their mandated liability insurance EURO 560 deductible approx Design fault Fabrication fault Instruction fault Possibly development fault Manufacturer of end product Assembler Component and material manufacturer Third country importer Retail merchant
49. the Electromag netic Compatibility Directive 89 336 EEC as amended by 93 68 EEC Safety Standards EN 292 1 2 1991 EN 60204 1 1993 EN 1050 1996 EN 1088 1996 EN 954 1 1992 EN 614 1 1995 EN 418 1992 EN 349 1993 EN 294 1992 Safety of Machinery Basic concepts general principals for design Safety of Machinery Electrical equipment of machines General requirement s Safety of Machinery Risk assessment Safety of Machinery Interlocking devices associated with guards Safety of Machinery Safety related parts of control systems General principals Safety of Machinery Ergonomic design principles Safety of Machinery Emergency stop equipment functional aspects Safety of Machinery Minimum gaps to avoid crushing of parts of the human body Safety of Machinery Safety distances to prevent danger to upper limbs Additional Safety Standards EN 60947 5 1 1991 Low Voltage switch gear amp control gear electromechanical control cir EN 60825 1 1994 EN 60447 1994 EMC Standards EN 55011 1991 EN 55022 1994 EN 50082 2 1995 Signature cuit device Safety of Laser Products Equipment classification requirements and user guides Man machine interface MMI Actuating principles Limits and Measurement of RFI for Industrial Scientific and Medical Equipment Limits and Measurement of RFI for Information Technology Equipment Generic Immunity for Heavy Industrial Environment name title location dat
50. the economic oper ator is not obliged to follow the European standards referred to in the directives OJEC 89 C 267 12 and that there could be more than one means of proof of conformity to a directive It provided for presumption of conformity to a directive on the basis of a European standard or during a transition period of national standards which have been submitted and recognized as equiv alent under a Community control procedure When the manufacturer complies with these standards the directives are there to allow him to make use of simplified certification mechanisms When the product does not conform to a standard however either because the standards do not exist or because the manufacturer in the case of innovation prefers to apply other manufacturing criteria of his own choice the assessment of conformity to the essential requirements must involve a third party EU body either by certification or by third party testing OJEC 89 C 267 20 Even though other means may be possible the harmonized standards route is the simplest and lowest risk alternative In practice the manufacturer should consider the use of harmonized standards advantageous to ensure their equipment s safety compliance and to establish a presumption of conformity The directives state National authorities are obliged to recognize that products manufactured in conformity with the harmonized standards EN published in the Offi cial Journal of t
51. the principles become clearer leading to cultivation of an almost inborn sense of how to interpret and apply the relevant requirements to achieve conformity The best advice I can give is to submit a sample product or prototype directly to a notified body for a design review or to a reputable consultant who in the end also obtains the safety EMC certificate and mark In many cases the evaluation can also be performed at the manufacturer s facility In the end it usually saves you considerable time and money if you use experts espe cially when you factor in the time it may take you to understand the standards and document the assessment Among the many benefits the notified body does the complete assessment and tests identifies product deviations and generates a report in a fraction of the time it would take you to do it yourself Also you can be sure the assessment and documentation are accurate and accepted by both customers and authorities U S and EU Differences United States U S and European Union EU standards and safety philoso phy are not equal interpretation and application of the European standards in the United States are oftentimes inconsistent with the EU experts interpretation and 70 CE MARKING HANDBOOK application The differences in safety philosophy are a matter of history culture and environment and frequently make it difficult for safety engineers operating on one continent to comprehend and accept the vie
52. to the compliant company But the accredited party does not give a product approval or CE marking With product quality it is the product itself that is subjected to conformity assess ment and certified according to product safety EMC standards by an accredited body and an approval mark is affixed to the product A factory s ISO 9000 certification does not typically encompass product quality with respect to safety or EMC A product s CE marking generally has no relevance to either fac tory or product quality The CE marking merely gives the impression that the manufacturer under stands the laws and standards but does not guarantee conformance with harmonized standards Self declarations such as the CE marking and other conformity claims are difficult to prove without independent verifiable support Sales and marketing claims may be questioned by potential customers especially when no independent evidence of compliance exists It is what is behind the claim that counts Trusting the initials CE to carry the product to success may not be enough In the end it is the consumer users or end product manufacturers who will make the decision by exer cising their right to demand evidence of conformity to assure themselves that the safety EMC quality of the product has met stringent European requirements aa The CE marking is not intended for marketing or sales and is not a quality marking of any kind Confidence in a product s safety E
53. with the relevant electrical mechanical component and other safety stan dards To ensure that machinery electrical hazards are addressed by machine manufacturers EN 60204 1 IEC 204 1 Electrical Equipment of Machines was pub lished in both the Low Voltage and Machinery directives and therefore electrical requirements must also be applied to machinery EN 60204 1 is a generic safety stan dard type B used in conjunction with the relevant machine safety standards type C ma A machine that complies with EN 60204 1 EC 204 1 is pre supposed to conform to the requirements of the Low Voltage Directive Design Guide for Safety Conformity 85 Some people assume that the term low voltage means safe voltages but as you have seen the LVD applies to products that operate at typical line mains voltages e g 230 400 volts in Europe and 120 208 volts in the U S that present shock and fire hazards Safe voltages are those less than 50 Vac 60 Vdc depending on the stan dard or term applied and are referred to as Extra Low Voltage or Safety Extra Low Voltage ELV SELV Ba The Low Voltage Directive applies to all safety aspects of electri cal equipment including protection from mechanical and other hazards As a designer you should first give careful consideration to the selection of the components and construction requirements which minimizes the risk that the prod uct will fail its first test thus causing costly product redesign Don
54. without defects The supplier and their network of distributors now must also retain the documentation for a longer time The documentation must be retained for 10 years after the last produc tion but may be required beyond this date if losses from a specific product occurred Without the documentation the suppliers will hardly be in a favorable position to defend themselves even if there were no defects A technical file includes the documentation that proves that a product conforms to relevant direc tives and standards The technical file is for market surveillance purposes and must be kept at the disposal of national enforcement authorities The documentation must be readily available to a duly substantiated request by enforcement authorities for inspection and control purposes Failure to make the documentation available may constitute sufficient grounds for doubting the presumption of conformity It is the manufactur ers or their authorized representative in Europe who are ultimately responsible for the accuracy of the technical file The technical files accuracy and the product safety EMC conformity are of paramount importance BA Technical files are for market control and must be readily avail able for the enforcement authorities 32 CE MARKING HANDBOOK The technical file consists of the technical documentation necessary to demon strate the conformity of the product to the essential requirements of the directives LVD EMC M
55. 06 0 Tetefax 069 6306 658 VDE Aseaciation of German Electrica Engineers Telefon international 48 69 8306 0 Merlanstraie 28 D 83069 Ottenbach VDE Form 77L 0596 L FIGURE 4 5 Electromagnetic Compatibility Certificate This Page Intentionally Left Blank CHAPTER 5 Quality and Enforcement Advice is what we ask for when we already know the answer but wish we didn t Erica JONG Product Quality versus Factory Quality As recognized by the Commission product quality is not automatically assumed with or without CE marking and must be earned Besides using European standardization as a means of improving the quality and acceptability of products it is necessary to enhance confi dence in the ability of the manufacturer to supply quality products This confidence cannot be simply imposed either upon public authorities or consumers it depends primarily upon the public attitude of the manu facturer himself i e it must be earned OJEC 89 C 267 16 The European and international standardization bodies have drawn up appro priate instruments procedures standards to assist manufacturers and inspection bodies obtain consistent factory and product quality through proper management of their quality systems EN 29000 ISO 9000 describes techniques for manufacturer s quality assurance systems and factories and accredited ISO 9000 auditors confirm these procedures through factory inspections and ce
56. 1 Equipotentiality Ha O IEC 417 5008 TEC 417 5007 IEC 417 5009 IEC 417 5010 On supply Off supply Stand by Push on Push off alternatively IEC 417 5011 Push button hold to run i IEC 417 5104 Start of action or operation TEC 417 5110 Stop of action or operation TEC 417 5264 On only for part of equipment of Peis ees Ee IEC 417 5265 Off only for part of equipment L seo IEC 417 5172 ISO 7000 1027 Equipment protected by Double or Reinforced Insulation Reset Note For additional symbols and more information refer to EN 60417 IEC 417 and EN 50099 Symbols courtesy of Hazard Communications Systems Inc HCS Milford PA FIGURE 6 5 Common Symbols Design Guide for Safety Conformity 103 maintained after a single fault to ensure adequate protection of the user This con cept is sometimes referred to as double improbability which means that there is always a second means of protection or insulation should the first one fail Double or reinforced insulation provides the required protection i e two levels before fault between live or hazardous parts and the user therefore even after a single fault has occurred the operator is still safe basic one level after fault With the single fault concept we can determine the protection needed to sat isfy the electrical safety standards such as basic supplement
57. 6 1 Organize appropriate checks on the safety of properties of products even after being placed on the market as being safe 2 Require all necessary information from the parties concerned Take samples of a product or a product line and subject them to safety checks 4 Subject product marketing to prior conditions designed to ensure product safety and requiring that suitable warnings be affixed regarding the risks that the product may present 5 Make arrangements to ensure that persons who might be exposed to a risk from a product are informed by publication of special warnings 6 Temporarily prohibit while carrying out the various checks anyone from supplying or exhibiting a product whenever there are precise and consistent indications that it is dangerous 7 Prohibit placing on the market a product or batch that has been proved dan gerous and 8 Organize the effective and immediate withdrawal of a dangerous product or batch already on the market and if necessary its destruction Ww Where a member state takes measures to restrict the placing of a product on the market or require its withdrawal the member state shall inform the European Commission of the measures specifying its reasons for adopting them The Com mission shall then enter into consultations with the parties concerned If the Com mission concludes that the measure is justified it shall immediately inform the member state that initiated the action and the othe
58. ANDBOOK the results of policing activities by enforcement authorities in Sweden gt 50 fail Germany gt 60 fail Finland gt 75 fail and elsewhere it is my view that the majority of products bearing only a CE marking do not comply with the European safety and EMC requirements or are questionable at best The art of oversell has reached new heights since the introduction of the so called coveted CE marking The CE marking is only the manufacturer s self declaration a do it yourself approach and does not in and of itself guarantee conformity and may not meet the customer s expectations CE markings do not ensure conformity and should not be used as a cover up Unfortunately some manufacturers use the CE marking and declaration as a shield for what they did or did not do The most infamous line is The CE marking is all you need In the legal sense this claim is true in the technical sense the claim is unfounded Legally the CE marking allows for the distribution of products practically speaking far more is required to satisfy technical safety requirements and users concerns Also CE does not limit liability and it is not intended for marketing sales or quality assurance purposes 9 Question If three products are placed on the European market with only the CE marking what s the difference between the products Answer One of the products complies with Europe s safety and EMC requirements a
59. Chapter 6 This book does not address all regulatory aspects for medical devices telecom products RF transmitters or other regulated products To reduce the number of equivalent or similar terms the following terms are considered interchangeable Europe s Approach to Total Harmonization 3 product machine equipment manufacturer supplier notified competent body In general the terms third party and notified competent body are considered equivalent and carry the same meaning in Europe Thus European accredited bodies third par ties are sanctioned to perform various assessment functions such as testing and or certification Definitions and Considerations Most all products must be assessed for conformity by either the manufacturer or an accredited body and bear the CE marking before entry into the EU The CE symbol indicates that the product conforms to the relevant directives and that the manufacturer has performed all the necessary assessment procedures Neither the quantity of products or machines nor the nature of the transfer relieves the manufac turer of performing the conformity assessment and affixing the CE marking The marking applies to all equipment put into service in a public or private capacity for professional or nonprofessional use or paid for or free of charge The key points dis cussed in this guide will be e Review of the EC directives Gain understanding of the legal and proce dural issues such as the essenti
60. G PARTS WARNING is allowed only when the hazard is directly involved in the production process and there are no other possible options i e guards interlocks stop switch sen sors Therefore if a guard or other protection means is possible it must be employed N Manuals Machine manufacturers shall deliver a machine that is safe to operate and therefore the operators instructions shall be in the language of the 128 CE MARKING HANDBOOK country the machine is intended for For machinery the complete operators manual with safety instructions shall be in a language acceptable in the country for its oper ation ref EN 292 2 EN 60204 1 89 392 EEC others Translation of the installa tion and maintenance instructions may also be necessary depending on the language of the installer and service personnel All manuals requiring a country specific lan guage must be translated by the equipment manufacturer supplier and made avail able prior to putting the product or machine into service The equipment manufacturer or supplier is responsible for transla tions Translation of the operators manual is a must Translation of service and installation manuals may also be required if requested by the cus tomer The language and translation requirements are mandatory and the equipment buyer or user may not accept liability for language translations O Technical Documentation Technical documentation necessary for the installation operation a
61. Household Appliances Note In some cases a type C product standard may not exist for a particular machine or product In this case type A and B standards are used along with the rel evant EU national standards if available to assess the machine for safety or EMC and these standards are then listed on the declaration of conformity for the CE mark ing Use of a EU notified competent body may be required for products where no type C standard exists Standards The Technical Rules 49 Essential Requirements and State of the Art In addition to the standards the manufacturer must check the essential require ments of the directives and take into account the generally acknowledged state of the art for EMC and safety Products machinery and components must be designed and manufactured in such a way that when used under the conditions and intended pur poses they will not compromise the health and safety of persons or the environment In selecting the most appropriate design solutions the manufacturer shall apply the following principles in order of preference 1 2 amp Inherently safe design Eliminate or reduce risks as far as possible by construction Guarding and safety components When a inherently safety design is not possible use proper protective measures such as guarding safety compo nents alarms in relation to risks that cannot be eliminated Warnings and instructions Inform users of residual risks due to shor
62. MARKING HANDBOOK DAVID LOHBECK a i A J 4 t ry i l p kgs y X oy 4 CE Marking Handbook Test and Measurement World Series D Lohbeck CE Marking Handbook A Practical Approach to Global Safety Certification A Afshar Principles of Semiconductor Network Testing S Scheuber Building a Successful Board Test Strategy CE Marking Handbook A Practical Approach to Global Safety Certification David Lohbeck M Newnes Boston Oxford Johannesburg Melbourne New Delhi Singapore Newnes is an imprint of Butterworth Heinemann Copyright 1998 by Butterworth Heinemann Q A member of the Reed Elsevier group All rights reserved No part of this publication may be reproduced stored in a retrieval system or transmit ted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior written permission of the publisher Recognizing the importance of preserving what has been written Butterworth Heinemann prints its books on acid free paper whenever possible aumea ranu Butterworth Heinemann supports the efforts of American Forests and the RELLA Global ReLeaf program in its campaign for the betterment of trees forests 2000 and our environment Library of Congress Cataloging in Publication Data Lohbeck David 1950 CE marking handbook a practical approach to global safety certification David Lohbeck p cm Test and measurement world series Incl
63. MC quality must be earned and verified through a system of independent checks and balances An approval mark on the equipment is always advisable for if there is no mark on the equipment the buyer may check for conformity thus increasing risk To Quality and Enforcement 67 check the quality and conformity of a component product or machine the consumer or end product manufacturer may demand a fest report for review and verification purposes The manufacturer s technical file is not required as it contains confidential information and is reserved exclusively for the authorities The safety and EMC test reports however should be readily available to anyone After receiving the test report you should seek a safety expert s opinion on the test reports accuracy and content 7 If the test report is not available the customer may doubt the presumption of conformity just as an enforcement authority or testing body would As stated in the Global Approach to Conformity Assessment the national practices of certain member states in some industrial sectors rely on the manufac turer to ensure conformity to mandatory safety requirements while others require third party notified body intervention The choice of mechanisms to be applied and the procedures for applying them vary between member states and from sector to sector as does the use of voluntary or mandatory certification This variation is due to the relative importance attached
64. Manufacturers Test Scheme Testing by Manufacturer Scheme Technical Committee Technical Construction File Test at Manufacturer s Premises Test Report Format officially recognized EU format Technischer Uberwachungs Verein Technical Surveillance Association Verband Deutscher Elektrotechniker Association of German Electrical Engineers Appendix B Information Sources Standards American National Standards Institute ANSI 11 West 42nd Street New York NY 10036 tel 212 642 4900 fax 212 302 1286 British Standards Institute BSI PO Box 16206 Chiswick London W4 4ZL UK tel 011 44 181 996 7000 fax 011 44 181 996 7001 Global Engineering Documents 15 Inverness Way East Englewood CO 80112 tel 800 854 7179 fax 303 397 2740 International Electrotechnical Commission IEC 3 rue de Varemb PO Box 131 1211 Geneva 20 Switzerland tel 011 41 22 919 0228 fax 011 41 22 919 0300 International Organization for Standardization ISO Case Postale 56 1211 Geneva 20 Switzerland tel 011 41 22 7490336 fax 011 41 22 7341079 VDE Verlag GmbH Bismarkstrasse 33 10625 Berlin Germany tel 011 49 30 348001 0 fax 011 49 30 3417093 Directives Office of the European Union and Regulatory Affairs US Dept of Commerce Room 3036 14th amp Constitution Ave N W Washington D C 20230 tel 202 482 5276 fax 202 482 2155 Office of the Official Publications of the EC 2 rue Mercie
65. Quasi manufacturer Fiction of the inclusion of the task range of an OEM supplier as if the product was manufactured by the OEM supplier FIGURE 2 4 Liability for Defective Products in Germany and Europe Courtesy of R amp L Ing Cons GmbH 65479 Raunheim Germany e That the state of technical knowledge at the time they put the product into circulation was not such as to enable the existence of the defect to be dis covered or e In the case of a manufacturer of a component that the defect is attribut able to the design of the product in which the component was fitted or to the instructions given by the manufacturer of the product 26 CE MARKING HANDBOOK It is not reasonable to make the producer liable for an unlimited period for the defectiveness of a product therefore liability should expire after a reasonable length of time without prejudice to pending claims Member states shall provide a limita tion of three years for the recovery of damages which begins to run from the day on which the plaintiff became aware or should reasonably have become aware of the damage of the defect and of the identity of the producer As shown in this section there are only a few defenses for the manufacturer such as it did not intend to market the product in Europe or exonerating circum stances The producer will however be liable for defective products that cause damage especially when it has a view to placing i
66. S and EU differences exist is in production testing In addition to a product s initial safety assessment and tests type tests all electrical products and machines must undergo routine electrical safety testing during the pro duction process see Design Guide Production Tests in Chapter 6 These tests are performed to detect any safety defects in the manufacturing process and materials As a minimum the European safety standards and certification bodies typically require two production tests for equipment i e computers machines and compo nents i e power supplies one for electrical strength hi pot and another for resis tance of protective earth ground continuity For example European standards EN 60950 and 50116 Type Tests and Routine Tests for Information Technology Equip ment require these two production tests In the United States however only the hi pot test is required for most NRT listed products even when these are certified to International standards i e IEC 950 EN 60950 Furthermore hi pot and ground tests may not be required no tests in production for some critical components such as power supplies even when they bear a NRTL recognition mark Quality and Enforcement 73 U S NRTL safety marks are restricted to listings for products and recogni tions for components Listing or Recognition means the product or component was evaluated and passed the tests but they are not approvals The European approv
67. Use functional markings such as ON OFF START STOP symbols for all controls and indicators whenever possible unless their function is obvious Proper markings and colors are important especially if the control or indicator in question is related to safety Green and red are controlled indicator colors with a red light used to indicate an Emergency condition that instructs the user to disconnect the power to the equipment A green light shows a normal power run or ON condition Yellow is a warning color used to indicate an impending hazardous condition see EN 60073 Some standards may permit alternate colors such as in coffee makers or film pro cessing products Most safety standards cover the specific information required for safety functions and markings 8 The Single Fault Concept The European safety standards stress an important principle called the single fault concept that is at the core of safety philosophy This principle states that even under a single fault a wire coming loose component failure short open circuit insulation failure etc at least one level of protection basic insulation must be 102 CE MARKING HANDBOOK Symbol Publication IEC 417 5031 Description Direct Current IEC 417 5019 TEC 417 5020 i IEC 417 5032 Alternating Current NY ll IEC 417 5016 Fuse bes 417 5017 Earth Terminal Protective Earth Terminal PE Frame or Chassis Terminal IEC 417 502
68. Victims Rights 22 Customs Authorities and Border Controls 26 Conformity Assessment Procedures The Modules 27 Technical Files Documentation and Test Reports 31 Declaration of Conformity 33 CE Marking Guidelines 33 Standards The Technical Rules 41 Harmonized Standards Presumption of Conformity 41 Selecting Standards 46 Essential Requirements and State of the Art 49 Notified Bodies and Certification 53 Notified Bodies and Third Parties 53 Testing Certification and Approval Marks 56 Defense of Due Diligence 57 vii viii CE MARKING HANDBOOK Chapter 5 Chapter 6 Quality and Enforcement 65 Product Quality versus Factory Quality 65 Consultants Benefits and Limitations 68 U S and EU Differences 69 The Quality and Safety Mindset 75 Market Surveillance 76 Enforcement 77 Example 1 EMC Enforcement in Europe 78 Example 2 Product Safety Enforcement in Finland 80 Example 3 Product Safety Enforcement in Sweden 80 Legal Requirements and Market Demands 81 Design Guide for Safety Conformity 83 Introduction Electrical Safety for Products and Machines 83 Principles of Safety 85 Design Guidance 88 1 Component Safety and Liability 89 2 Component Selection and Conformity Verification 93 3 Constructional Data Forms CDF 95 4 Equipment Classification 98 5 Power Consumption 99 6 Rating Label 100 7 Markings and Indicators 100 8 The Single Fault Concept 101 9 Input Wiring Terminations and Identification
69. accessible parts and live parts via insulation layers thickness and or dis tance creepage and clearance There are three classes of equipment Class I II and HI with Class I and II products generally covered by the Low Voltage Directive e Class I equipment utilizes earth ground and are typically mains operated i e 115 230 400 Vac 3 5 wires electrical products such as desktop com puters test and measurement devices machines or stationary appliances e Class II products are ungrounded and rely on protective earthing 2 wires Examples include VCRs TVs power tools portable radios and other handheld or portable appliances Class HI products are generally considered electrically safe since they operate outside the specified voltage range of the LVD lt 50 Vac 75 Vdc Battery operated products operating outside the specified range are not covered by the LVD Products which generate internal high voltages are also excluded from the LVD s scope provided the high voltages are not accessible via sockets or other accessible parts The LVD is applicable however to battery operated Class III devices if they can be operated with a mains connected power supply or charger e g a laptop computer Design Guide for Safety Conformity 99 The mobility classification of the equipment is another important factor affect ing the products testing and construction requirements such as impact and drop tests leakage limits enclosure streng
70. achinery etc It shall cover the design manufacture and operation of the product The file may be in English or another EU language and should only address the safety EMC issues in other words kept to a minimum The contents of the file depend on the applicable directive but in general consists of the following Declaration of conformity e Name and address of the manufacturer General description and identification of the product List of harmonized standards applied Solutions adopted to satisfy essential requirements and rationale Examination results and calculations Test reports test data components lists certificates etc Design drawings circuit diagrams etc e Operation manual warnings etc and Measures adopted to ensure ongoing compliance Test reports are technical records on the conformity assessment of a product according to specific standards Test reports are concise accounts including clause by clause details on the results of the product assessment standards rationale test data construction and components Test reports are an essential tool for conformity assessment and the most important element of the technical file The manufacturer may obtain a test report as a element of proof of conformity from an notified compe tent body not mandatory in advance and keep it with the technical file The avail ability of such a report from a notified body would make matters easier a
71. afety laws include provisions for enforcement at the state level None of these laws or regulations contradict the Euro pean directives The German and European policies have raised the awareness of quality and safety for the buyer The directive on the Global Approach recognizes this The rea soning behind such policies is that the reputation of certain certification marks rep resents a strong commercial advantage to commercial trade OJEC 89 C 267 12 The so called technical barriers to trade are not new and have developed over decades and have only recently become apparent with enforcement of the CE mark ing The requirements were not erected to keep products out but more for a global harmonization to eliminate any barriers to trade and raise the level of all products quality and safety Market Surveillance Without effective market surveillance manufacturers begin to ask themselves why they should go through the costly process of CE marking when many of their competitors ignore it and get away with it Effective market surveillance at national and member state levels is a prerequisite for consumer confidence in the Single Mar ket Surveillance and enforcement are still in their infancy in Europe and have a long way to go The results of market surveillance have been spotty at best with some notable exceptions in countries such as Finland Germany and Sweden The Euro pean Commission publishes directives and standards that give
72. ages must be adequately earthed between these parts and the protective earth terminal Perform a ground continuity test on all user touchable metal parts at 25 A 12 V source or 1 5 times the limited input current 1 5 x fuse breaker rating depending on the standard The measured resistance must be less than 0 1 ohm for the ground continuity test Masking of paint and ground straps between metal doors and the chassis helps to ensure an adequate safety ground Grounding through hinges of metal doors is not considered adequate Ground straps or wires are necessary for all hinged metal doors that cover hazardous voltages to ensure an adequate safety ground One should not be able to disconnect the PE conductor during the servicing operation to replace any parts This means that the grounding stud or screw should not be used to hold any other replaceable part in place An isolated ground point is preferred and often required in some standards along with the protective earth sym bol D for connection of the PE wire only green yellow insulation Only one PE symbol is allowed in the product unless there is more than one power cord The chassis ground symbol may be used for other safety or chassis grounds In addi tion all ground terminations such as ring lugs must be reliably fixed and not Design Guide for Safety Conformity 107 allowed to turn Use a lock washer and nut for each ring lug even when these are stacked on the same ground st
73. aking all reasonable steps to ensure conformity With only a few exceptions the manufacturer importer is ultimately responsible for a product s compliance to directives but with a mark certificate or test report from a notified body the suppliers risks are decreased and their defense of due dili gence enhanced should the products safety EMC conformity come into question It is the responsibility of notified bodies to accurately interpret directives and stan dards through testing and certification thereby ensuring conformity and building consumer confidence tad Due diligence is a matter of record Over 100 000 products have received the GS Mark GS Safety Tested Numerous Type Approval Marks for components and EMC Marks have also been issued The increased marketing potential of certification and approval marks should not be overlooked As the Official Journal states Testing certification and inspection can also be an integral part of a national industrial policy intended to promote goods both nationally and internationally The reasoning behind such policies is that the reputation of certain certification marks i e VDE TUV BG represents a strong commercial advantage in international trade OJEC 89 C 267 03 58 CE MARKING HANDBOOK The objective is to manufacture and sell safe products and not waste time arguing with customers who challenge a product s conformity Designing and certi fying products to mee
74. al Data Forms CDF The critical component parts list or Constructional Data Form CDF is an important tool to aid in component selection their application criteria and verifica tion of conformity marks Figure 6 4 shows the CDF It is also extremely useful dur ing the design purchasing and manufacturing control of components used in the equipment The CDF is a listing of all safety sensitive components see Figure 6 3 for component types with the relevant technical data such as 1 component description 2 manufacturer s name and part number 3 rating information and 4 EU type approval marks found on the component From the CDF anyone can see at a glance which are the critical components for safety and most important it identifies the Euro pean type approval mark s found on the components right column of CDF Once the end product is in conformity with the relevant standards the CDF can be used by engineering purchasing and manufacturing to control the parts and ensure that the company uses only approved replacements or alternates Alternate or additional components can be easily added during design on the initial CDF or at a 96 CE MARKING HANDBOOK Product and Machine Components Machinery Specific Inlets and outlets Enclosures for elec controls Plugs and connectors e E stop switch Power cords e Service disconnect device Strain reliefs e Interlock switches RFI filters chokes caps e Position sensors Circuit
75. al designation certification used in association with a NRTL listing or recognition is often discouraged in the United States to limit any implied war ranty Furthermore the wording of some important terminology in the U S ver sions of IEC standards have been changed to reflect U S legal considerations The following passages illustrate differences in the U S and EU interpretations of the same base standard Europe s EN 60950 IEC 950 versus the United States UL 1950 Annex NAD Europe United States avoid the risk reduce the risk remain safe not introduce a hazard prevent a hazard to reduce the risk of injury of protection against reduction of risks of injury due to ensure protection against reduce the risk of the operator shall be prevented from means shall be provided to reduce having access to the risk of the operator having access to to provide adequate protection to reduce the risk of injury to per against the risk of personal injury sons so constructed that no dangerous so constructed to reduce the risk concentration of these materials can from dangerous concentration of exist and that no hazard within the these materials and to reduce the meaning of this standard is created risk created ensures that such testing will indicate indicates that the results of such test that the assembled equipment con ing will be
76. al requirements procedures enforcement and rules for CE marking e Discussion of compliance with European harmonized standards This is the most important element to meeting the ERs of the directives Products manufactured in conformity with harmonized standards are presumed to conform to the ERs of the directives e What s needed in conjunction with affixing the CE Marking With the product supplier s CE marking mandatory for most products the supplier s declaration of conformity and technical file must also be readily available on demand by enforcement authorities e Importance of voluntary certifications test reports and approval marks Although it is not mandatory for most products and machines voluntary certifications test reports and approval marks issued by EU certification bodies are the best means of showing a defense of due dili gence should a product become suspect by enforcement authorities com petitors or customers Due diligence means taking al reasonable steps to ensure conformity Regardless of the presence of the CE marking to achieve a higher level of quality and ensure safety EMC compliance customers can also demand an approval mark and or test report from an EU third party To understand European Conformity we must first be familiar with a few important terms The term equipment used in the standards can mean almost any product appliance or machine and therefore these terms are interchangeable
77. an harmonized standards provide specific technical safety EMC design testing and pass fail rules for components products and machines Standards are the cornerstone of the New Approach and without them the Single Market could not function The EU standards referred to in the directives provide a presumption of conformity for equipment manufactured in accordance with these standards Without properly applying EU standards equipment will not benefit from a pre sumption of conformity conferred by the use of such standards e CE marking CE is the equipment manufacturer s self declaration symbol to indicate the equipment s conformity with all relevant directives In addi tion to the CE symbol the manufacturer s declaration of conformity and technical file must be readily available The CE marking and declaration together are a passport for trade that indicates conformity to customs inspectors and authorities allowing products to be placed on the market and that ensures the free movement of goods They also give enforcement authorities the ability to withdraw non conforming products and to take appropriate measures CE is applied to complete products and is not intended for most components The CE marking is not a safety EMC guar antee from a third party notified body or quality mark and it is not intended for sales or marketing purposes Conclusion 139 Step 1 Identify all applicable Directives and S
78. any case must comply to the relevant EN IEC component standards UL CSA flammability classification may be acceptable Refer to the standards or consult a EU body for the requirements regarding flammability ratings i e 94V X battery types protection cir cuits and testing Safety components such as light curtains sensor mats and two hand controls are regulated by Machinery Directive 89 392 EEC which requires a manufacturer s declaration of conformity but no CE marking EU type approval marks are also highly recommended for safety components Lohbeck FIGURE 6 3 Components Requiring Evidence of Conformity Type Approval Marks Design Guide for Safety Conformity 97 TUV Rheinland Certificate No File No Attachment No of North America Inc S98XXXXX 141 DLAVES7XXXXX 01 1 TUV to be filled in by TUV Rheinland of North America Inc Rheinland Constructional Data Form page 1 of X Applicant Manutacturer XYX Corp Rated Voltage AC 118 230 V 60 50Hz Type of Equipment Personal Computer Rated Input 422A Type or Mode No RMS XY X 0 9 Y A Z Protection Class Class 1 Classi D Ctass itl Bult in critical components switches inlets capacito if slo thon devices provai mark s in the right column CE and IEC not omplete table below with EU valid ULICSA considered for plastics flammab approval kind of component manufacturer and part number information about type current power etc ma
79. appraisal and certification activities for which it is notified Testing may be subcontracted to audited laboratories by the notified body but only by order of the EU body and under direct supervision and procedures set down by the body Only the European body s validated test report certificate and approval mark for the product in question has the support of the EU notified or com petent body Some consultants and test labs improperly issue so called certifi cates In Europe this right is exclusively reserved for EU accredited cer tification bodies Compliance with all relevant directives and standards will not guarantee a safe product or prohibit authorities from taking action against products that are found to be dangerous but verifiable conformity to the minimum requirements e g the har monized standards goes a long way Some consultants suggest using the directives general essential requirements over the specific design and testing requirements contained in the standards Buyer beware Equipment s Conformity in Question Some man ufacturer s focus on the directives essential requirements as a way to get around the safety EMC rules standards In these cases there is no presumption of conformity Most laws and standards are based on common sense and experience By trusting the experts and garnering knowledge from them you yourself can learn to apply the standards properly With experience
80. ary or reinforced insulation In addition it is through single fault analysis that the number and type of abnormal tests are determined Perform a detailed safety fault analysis to deter mine which faults can occur to establish the proper insulation type s and identify the abnormal testing required Using European type approved components and construction techniques i e proper thickness sleeving and double fixed termina tions for internal wires greatly reduces the fault testing involved Fault testing of nonapproved components such as power supplies can often cost more than testing the product or machine itself and the component oftentimes fails anyway The scope of this section is purposely limited and assumes that all critical components bear European type approval marks There are other books and standards that the manufacturer can refer to for component assessment and testing see previous com ponent sections 1 to 3 to limit risks Machines safety circuits sometimes require special components such as relays contactors interlocks and E stops Common terms associated with these machine components are control reliable fault tolerant and fail safe which means that they fail to a safe condition after a single fault not multiple faults 9 Input Wiring Terminations and Identification All wire sizes and insulation must be suitable for their intended use and rating Since wiring is oftentimes critical to safety it should have the pro
81. ase 01 97 IEC 950 19914 41 1992 A2 19934A3 1995 Ad 1996 modified EN 60950 1992 A1 1993 A2 1993 A3 1995 A4 1997 Safety of IT equipment 150 9241 3 1992 EN 29241 3 1993 Visual display requirements 150 9241 8 1997 EN iso 9241 8 1997 imeni for displayed colours Remarks Graphic contralier XYZ 2000 The type tested meets the requirements specified in article 3 para 1 of the Equipment Safety Act GSG 3 Abe 1 Thus the type tested also complies with the provisions taid down in the directive 73 23 EEC Electrical Equipment amended by the directive 93 68 EEC The holder of the certificate is entitled to affix the GS mark shown overleaf to the products complying with the type tested At that the holder of the certificate shall observe the conditions specified overleaf The present certificate including the right to affix the GS mark will become invalid at the latest on Further provisions concerning the validity the extension of the validity and other conditions are laid down in the Rules of Procedure for Testing and Certification of October 1997 Signature Postal address Office Phone O 40 51 46 27 76 Desib genkamp 4 Deelbdgenkamp 4 Fax 0 40 51 46 20 14 22297 Hamburg 22237 Hamburg In any case the Garman originai shel provali FIGURE 4 3 Product Safety Certificate N Nemko Group 63 92000 Model type Data Other specification The above product is certified according to th
82. at requires a Certificate of Conformity issued by a competent body prior to CE marking Under the TCF route the manufacturer may place the CE marking on the product only after satisfactory testing completion of the TCF and receipt of the Certificate of Conformity from the competent body The TCF process is often times used when there are numerous product variations or for large machines Declaration of Conformity The EU declaration of conformity is the procedure whereby the manufacturer or authorized representative ensures and declares that the products concerned sat isfy the requirements of the directives that apply to them The declaration of confor mity shall be signed by the manufacturer wherever located or by the authorized representative established within the Community The LVD and EMC Directives state that the declaration needs to be kept on file but manufacturers may also supply a declaration with each product or shipment For machinery a declaration must accompany each machine The declaration shall be in the same language as the orig inal instructions for use The declaration of conformity shall contain the name and address of manufacturer or representative description of product name model number etc directive s declared harmonized standards applied additional stan dards and specifications where appropriate place and date of issue and name and signature of authorized person The format is not importa
83. ation of stan dards Variance from this procedure is not at the manufacturer s discretion When choosing standards consider the following points 1 Type of product Check the scope of the standard to determine if it refers to the product 2 Environment Make sure the standard deals with conditions of usage 3 User The skill and protection of the operator and service person are important 4 Other considerations Other standards may be applicable such as for non tested components environment guarding state of the art ERs of direc tives see Essential Requirements below RA Tunnel vision is commonplace for beginners Assuming only one standard applies or applying the improper standards and not addressing all the ERs of the directives may lead to nonconformity Standards The Technical Rules 47 Beware of the dangers of tunnel vision Manufacturers may limit their view machine builders may focus on the mechanical guarding issues ignoring the elec trical electrical product manufacturers may address the electrical concerns ignoring the mechanical Manufacturers must address all hazards even when a standard does not mention a specific hazard see Essential Requirements below If an electrical product LVD has a potential hazard such as mechanical or laser that is not covered by the relevant electrical safety standard then the designer must identify other standards to address these issues In addition if critical com pone
84. ational require ments As a minimum one mark for North America UL and one for Europe VDE should be considered Many component suppliers now offer components with this dual certification A certificate and test report from the testing and certification body supports the type approval mark The mark is affixed to the component and is visually recognized by interested parties as positive evidence of compliance v Learn to recognize EU approval marks Look at a component and identify European approval marks such as 7 y AN AE EEROR VRO O Ro Know and recognize the many European approval marks on components These symbols and logos from EU certification bodies give the consumer the added assurance they demand Also be able to differentiate approval marks from self declarations As mentioned there is no such thing as an IEC or CE Approval Approvals and certifications are granted only by European accredited testing and certification bodies The alpha characters IEC and VDE sometimes found on com ponents and in marketing literature are a reference to the standard that the compo nent supplier claims to meet and are not independent EU third party approvals Do no confuse the self declaration markings alpha characters not symbols of IEC or VDE or CE on the component or in a sales brochure for a type approval mark If in doubt contact a European body for verification The following are sta
85. ations continue today in Germany and some other countries See chapters on Notified Bodies and Certification Chapter 4 and the Quality and Safety Mindset Chapter 5 The New Approach 1985 Prior to 1985 trade quality safety EMC and other areas differed among many EC now EU states Each country established its own laws and standards and even when the EC attempted to harmonize standards national deviations existed that limited the reform efforts These internal restrictions not only made it difficult for European Community States to trade with other EC countries but also the restric tions were beginning to leave Europe behind in the world market Europe needed to reduce the cost of its products and services to compete in the global market and maintain acceptable employment levels Harmonization started in 1957 with the Treaty of Rome and the founding of the European Economic Community EEC Even so competition from overseas was outpacing the reforms and standardization in Europe was moving too slowly To achieve a unrestricted free market within Europe drastic action had to be taken and fast One action was the removal of tech nical barriers to trade which then became a major factor in the promotion of indus trial quality and of the competitiveness of European firms both on the internal market and beyond So a principle of European directives laws and standards technical rules called the New Approach was introduced in 1985 an
86. breakers Contactors Fuses user accessible e Relays ind types Fuseholders e Circuit breakers ind types Mains disconnect switch Fuses internal and external Power supplies e Function controls switches External supplies e Push buttons and switches Fans AC and DC Indicator lights and towers Terminal blocks e Heaters and elements Relays e Solenoid valves Disk drives all types Alarms audio and visual Thermal cutouts e Robots and controls Current limiting devices PLCs drives and controllers Voltage select switch e Flat panel displays CRTs monitors etc Products PCs VDUs UPS Transformers air conditioners lighting etc Motors e Safety components Printed circuit boards Others Plastics and enclosures Conductive coatings Wire insulation Air filters Batteries Others components gt 50 Vac 60 Vdc Components in safety circuit regardless of voltage i e 12 24 Vdc operation CE markings and declarations are not considered as evidence of conformity Components bearing the appropriate European type approval mark VDE TUV need only to be checked for proper application in the end product Components without an approval should be assessed and tested accord ing to the relevant EN IEC component standard and for application in the end product Type approved transformers or motors are in some cases difficult to source especially the larger types but in
87. c which in turn limits risks to the product manufacturer and supplier The product assessment procedures and design requirements are well established and defined within Europe s New Approach However in the few cases where there may be doubt it is always prudent to err on the side of consumer protection Only those seriously interested in limiting their risks by putting consumer protection first should read on CHAPTER l Europe s Approach to Total Harmonization Every man has a right to his opinions But no man has a right to be wrong about his facts BERNARD BARUCH The European Union and the CE Symbol The European Union s EU goal of single market access has finally arrived For the most part it appears to be working The EU s New Approach has reduced or in many cases eliminated the legal and technical differences between the member state countries that existed under the Old Approach The CE marking is a symbol of the manufacturer s self declaration indicating that the product or machine conforms to all relevant European regulations The requirements are contained in the various European directives laws and standards tests and design Directives along with the appropriate European standards cover all safety electromagnetic compatibility EMC health and environmental con cerns CE marking of machinery came into effect on January 1 1995 and EMC con formity has been required since January 1 1996 Electrical prod
88. ccording to all the requirements must be under taken and documented in the manufacturer s technical file before anyone can affix a CE marking and place a product on the market make it available or put it into service A technical file is required by the primary directives to document the confor mity assessment and the product s design The technical file shall be compiled by the manufacturer or authorized representative and contain design documentation manufacturing procedures test reports and operation information to show confor mity as required by the directives A technical construction file is a special file for regulated products high risk machines Annex IV machinery and occasionally utilized for EMC large equip ment etc where the use of a notified or competent body is mandatory Test reports are technical records on the conformity assessment of a product according to specific standards Test reports are concise accounts including clause by clause details on the results of the product safety EMC assessment standards rationale test data construction and critical components Test reports are an essen tial tool for conformity assessment Test reports contain the technical results of the conformity assessment and need not contain confidential design information Test reports may be requested by customers testing certification bodies or enforcement authorities for review and verification purposes A declaration of conform
89. ccording to the harmonized European Standards as mentioned below in conjunction with article 10 1 of EC Directive 89 336 EEC of 3 May 1989 transfered into German national law Gesetz ber die elektromagnetische Vertr glichkeit EMVG vom 9 November 1992 the equipment described in this marks licance document meets the essential requirements of the electromagnetic compatibility EMC Europ ische Norm Deutsche Norm VDE Klassifikation European Norm German norm VDE classification EN 55022 1994 DIN EN 55022 1995 05 VDE 0878 Teil 22 1995 05 Grenzwerte fiir Einrichtungen der Klasse B Limits for class B equipment EN 55022 A1 1995 DIN EN 55022 A1 1995 12 VDE 0878 Teil 22 A1 1995 12 EN 61000 3 2 1995 DIN EN 61000 3 2 1996 03 VDE 0838 Teil 2 1996 03 EN 61000 3 3 1995 DIN EN 61000 3 3 1996 03 VDE 0838 Teil 3 1996 03 EN 50082 1 1992 DIN EN 50082 1 1993 03 VDE 0839 Teil 82 1 1993 03 Produktbeschreibung Notebook Personal Computer 8 0 Product description Typbezeichnung PC 123 0 8 Type reference Nennspannung DC 18 V Rated voltage ber externes Netzger t via external power supply AC 100 240 V 50 60 Hz Stromaufnahme max 1 5 A bei DC 18 V at DC 18 V Rated current Schutzklasse 1 ill Protection class Fortsetzung siehe Blatt 3 continued on page 3 8 8 VDE Testing and Certification Institute Institut VDE d Essais et de Certification VDE Verband Deutscher Elektrotechniker V Telefon national 069 83
90. cement trends for EMC product safety and machinery are as follows Example 1 EMC Enforcement in Europe The European EMC authorities have been very active since the EMC direc tive came into force So far the most rigorous enforcement has been in Germany and Sweden with the United Kingdom Italy and others to follow suit The author ities are checking manufacturers technical documentation declarations and test ing products resulting in further investigation prosecution and in some cases product withdrawal from the market In Sweden products are removed from the market as soon as they are identified as noncompliant Estimates of noncompliant products range from 30 to 50 depending on the country and industry sector and whom you speak to During 1996 in Germany alone 1 500 technical documents were reviewed each month and 750 were passed to regional offices for further investigation Many companies have received fines Of the products tested 61 had incorrect declarations of conformity 28 had problems relating to the CE mark ing and 11 had technical shortcomings Germany s version of the European EMC directive known as the EMVG allows enforcement authorities to impose fines for nonconformity without taking companies to court This helps to fund fur ther enforcement activities in Germany The German market for products is about one third of the entire European market These examples are only the tip of the ice berg and nume
91. cial Journal OJEC 95 C 326 50 The first five questions and answers are repro duced here Q 1 Does the EC verification mark on a product guarantee free access to the whole internal market for the product concerned A 1 Yes The CE marking can be described as a passport for indus trial products allowing them to circulate freely throughout the European Economic Area EEA It is a mandatory conformity marking which shows the compliance of products with all provi sions of 16 Directives which relate to safety public health con sumer protection or other essential requirements of community interest Q 2 Is the EC verification mark recognized in all countries of the European Union A 2 Yes It addresses the market surveillance authorities of the mem ber states and aims to facilitate their surveillance tasks by visibly demonstrating conformity Of course where a member state ascertains that products bearing the marking do not comply with the requirements of the directives applicable it takes appropriate measures to withdraw the products from the market to prohibit the placing on the market and putting into service and to restrict free movement Q 3 Is the Commission aware that in some countries in the Union other seals of approval are still in use in addition to the EC verifi cation mark 38 CE MARKING HANDBOOK CE Guidelines Symbolizes conformity to all obligations on the manufacturer by virtue of the directives and
92. ction requirements Whereas pending the adoption of harmonized standards the free movement of goods should be facilitated by accepting apparatus complying with the national standards Member states shall presume compliance with the protection requirements referred to Article 4 in the case of apparatus which is in conformity with the relevant national standards transposing the harmonized standards or with the relevant national standard in the areas covered by such standards no harmonized standards exist Notes The above quotes are taken word for word from the relevant EU Directives The LVD EMC and Machinery Directives are amended by 93 68 EEC adding the CE Marking Directive 90 683 EEC men tioned in 73 23 EEC is replaced by 93 465 EEC Lohbeck FIGURE 3 1 Directives Require Harmonized Standards for Presumption of Conformity 44 CE MARKING HANDBOOK Standards Organizations Primary Subject Standards Examples IEC International Electro Electrical Safety IEC 65 204 335 CISPR technical Commis EMC 950 1010 CISPR sion EMC section 11 14 22 of the IEC CENELEC European Committee Electrical Safety EN 60065 60204 for Electrotechni EMC 60335 60950 cal Standardization 61010 EN 55011 55014 55022 CEN European Committee Mechanical and EN 292 349 418 for Standardization System Safety 954 1050 ISO International Organi general ISO 9000 9241 zation for 14000 Standar
93. d certified listed or recognized by U S labs to their so called equivalent UL IEC standard The results have been surprising and disconcerting with the vast majority of these pretested products failing the requirements when tested by a European accredited body i e VDE TUV It is this author s opinion that the majority of components prod ucts and machines fail safety tests when assessed by a European noti fied body even when they were pretested to international standards EN IEC by the manufacturer consultant or U S agency see Enforcement below and CE s Credibility at Risk in Chapter 7 Problems that are often encountered with U S safety testing according to European requirements include e Inappropriate standard applied Applying one standard when several are applicable e Safety issues unsatisfied when not addressed in standard at hand e Not considering all requirements for environment industrial hazardous locations moisture e Focus on fire and tests U S instead of shock and construction EU requirements e Risk assessment inadequate or not performed Testing or fusing in lieu of construction and other requirements e Enclosure and hi pot test box it and pot it to cover nonapproved components e Production testing inadequate or not performed e Warning labels used where guarding interlocks or other fail safe measures required e Manuals warnings labeling and languages not in orde
94. d has gained momentum ever since Figure 1 1 shows a history of EC directives LU Directives issued before 1985 are considered Old Approach directives except when amended after this date as is the case for the Low Voltage Directive LVD 73 23 EEC amended by 93 68 EEC add ing the CE marking The LVD is valid under the New Approach Europe s Approach to Total Harmonization 9 1872 TUV founded in Germany for industrial safety Accident Insurance Act enacted in Germany for Insurance and Trade 1S Cooperative Associations BGs 1893 VDE founded in Germany for safety of electrical products IEC established for safety criteria in electrical industry and international trade German RFI Law HfrG implemented for electrical products limits RF 1949 ie emissions 1957 Treaty of Rome Initiates the single market concept for free trade J 1968 German Equipment Safety Law GSG All products shall be safe per releva standards 1973 CENELEC formed to coordinate standards activities 1 Low Voltage Directive 73 23 EEC issued for electrical product safety i O EE 1985 New Approach initiated for harmonized directives and standards Single European Act Area without borders for free movement of goods personnel etc 1987 Global Approach supplement to New Approach for conformity assessment and CE Marking EMC Directive 89 336 EEC issued for elec
95. depending on their expe rience knowledge cost and most important the advice they give There are some very good consultants but you should be aware of their benefits and limita tions If you the manufacturer decide only to self declare a product s conformity for the CE marking then using the services of a reputable and experienced consult ant may be beneficial Consultants may improve the product manufacturer s chances of conformity but beware of a false sense of security I call it the feel good fal lacy Even with a consultant the product manufacturer will be liable for all the work performed by themselves or the consultant because it is the manufacturer whose name is on the product and the one who signs the declaration of conformity y Liability cannot be reduced by or shifted to a consultant Consultants and outside testing labs are not third parties As mentioned the European terms third party and notified body are interchangeable and signify Bodies Notified to the Commission as listed in the OJEC see Notified Bodies and Certification in Chapter 4 A consultant may be knowledgeable in one field but carefully check out those who offer the so called one stop shop for U S amp EU Safety amp EMC Many of these shops actually specialize in only one area such as U S EMC FCC and have a much lower level of competence in other areas Marketing and misleading advertising have reached a new high since the
96. dered wires are not con sidered adequately fixed unless they are held in place near the termination indepen dently of the soldered connection 110 CE MARKING HANDBOOK Openings in enclosures tops sides and bottoms shall comply with the dimen sional requirements of the relevant product or machine standards The restrictions are necessary to prevent objects from entering the product via top or sides and pre vent in the event of fire flaming particles from exiting the bottom of the enclosure Examples of enclosure opening sizes are e Top and side openings 1 not exceed 5 mm in any dimension or 2 not exceed 1 mm in width regardless of length or 3 for tops be so constructed that vertical entry of falling object is prevented from reaching bare parts by means of a trap or restriction or for sides provided with louvers to deflect an external vertically falling object or so located that an object entering the enclosure is unlikely to fall on bare parts at hazardous voltages Bottom openings 1 baffle plate construction see EN 60950 or 2 metal wire mesh not greater than 2 x 2 mm and a wire diameter of not less than 0 45 mm or 3 size and spacing of holes in metal bottoms i e 2 mm diameter hole max x 2 mm spacing min for a 1 mm min thick metal bottom 15 Warnings Instructions and Languages With the advent of strict liability in Europe the duty to warn viewpoint has recently been expanded in the courts to a cons
97. dization Note In 1997 the IEC introduced a new numbering system for all its international stan dards Existing standards also adopt this new numbering system for example IEC 65 is now referred to as IEC 60065 The first step in the development of a standard begins with the European Com mission mandating that a standards organization draft a standard Next a closing date is established and within this time period all interested parties may comment After approval the standard will be published as an harmonized standard in the Offi cial Journal and then it is transposed into national standards by the member states A standards implementation example would be EN 55022 1994 Limits and Methods of Measurement of RFI Charac teristics of ITE e DOR 12 09 1992 Date of ratification by technical board e DOA 03 15 1993 Date by which EN may be announced at national level e DOP 12 15 1994 Date when EN is transposed into national standard DOW 12 31 1995 Date when national standards conflicting with EN must be withdrawn European standards are clearly the main path toward conformity Although use of European standards is voluntary in one sense European harmonized standards have become the technical governing rules and are in reality the obligatory way for manufacturers to reduce unnecessary risks and to meet the EU directives In prac tice only published European harmonized standards such as ENs EN European Norm should be used to
98. door interlocks and grounding kits Caution U S NEMA class and European IP ratings are not always equivalent NEMA 12 4 IP 54 Both the dust and water tests must be performed according to EN 60529 with passing results Enclosures often fail the IP requirements especially the dust tests It is best to use a type approved and marked VDE TUV enclosure to ensure conformity K Functional Markings Functional markings should be used for all controls switches and indicators whenever possible unless their function is obvi ous Proper markings and colors are essential if the control or indicator in question is related to safety Red green and yellow are important push button and indicator colors and strictly controlled by the standards for safe operation of the equipment A red light is used to indicate an emergency condition and instructs the user to operate the emergency stop E stop thereby disconnecting power to the equipment A green light shows a normal or run condition and is commonly used as a power ON indicator Yellow is used as a warning to indicate an impending hazardous condition may occur and instructs the user to take appropriate action Most safety standards 122 CE MARKING HANDBOOK Ist digit Protection from solid objects Protection from moisture Protected against Protected against solid objects greater dripping water than 50mm VU fam te Protected against w Protected against solid objects greater drippi
99. e Note If or when a machine safety standard type C is published for this machine type some of the safety standards are then superseded by it FIGURE 2 7c Sample Declaration Machine Directives and Procedures 37 rx There is no marketing advantage with only the CE marking since all products will have the CE marking Products with the CE marking are therefore assumed equal by customs inspectors but cus tomers may expect more The CE marking is affixed at the end of the production phase by the manufac turer In exceptional and duly warranted cases the manufacturer s authorized repre sentative or the person responsible for placing the product on the market may be allowed to affix the CE marking The CE marking must be affixed to the product itself In certain cases the Directive does allow the CE marking on the packaging such as when the product s size is too small Other conformity marks indicating compliance with European standards are allowed provided they are not liable to deceive third parties as to the meaning of the CE marking and provided such marks do not cause confusion with and do not reduce the visibility of the CE marking Figure 2 8 shows the general guidelines for the CE marking Written questions concerning the CE marking were posed by a member of the European Parliament to the Commission The answers were given by Vice President Mr Bangemann on behalf of the European Commission and published in the Offi
100. e Inc ABC Machine Inc Model XXXX Model XXXX Model XXXX 3 N AC 400 V 3 PEN AC 400 V 3 N PE AC 400 V 50 A 50 Hz 32 A 50 Hz 125 A 50 Hz Four wire with Four wire with Five wire with neutral neutral and pro neutral and pro tective function tective earth 7 Markings and Indicators Manual control devices shall be clearly and permanently designated with regard to their functions on or adjacent to the actuator such as the OFF symbol O and Design Guide for Safety Conformity 101 ON symbol If only a part of the product is switched off the standby symbol may be used Numerous other symbols exist for switch and control indications such as for push push or hold to run Figure 6 5 shows some examples of symbols Fuses whether internal or external accessible shall be marked with fuse type and rating adjacent to the fuse The fuse symbol is also recommended but not mandatory Use only IEC symbols for the fuse ratings and type F fast acting T time delay M medium time delay A table listing the fuse number and rating may be used where several fuses are found in one location Examples of fuse markings are F5 A 250 V or T2 5 A 600 V or M1 25 A 250 V F1 F5 A 250 V F2 F3 A 250 V 230 V input T3 A 250 V F4 T1 5 A 250 V Fuse rating for U S products only Outlets internal or external also need the voltage and maximum power markings next to the outlet such as 2A 250 V Maximum
101. e clarifies the issue of CE marking for components stating In general the scope of the Directive includes both electrical equipment intended for incorporation into other equipment and equipment intended to be used directly without being incorporated However some types of 90 CE MARKING HANDBOOK electrical devices designed and manufactured for being used as basic components to be incorporated into other electrical equipment are such that their safety to a very large extent depends on how they are inte grated into the final product and the overall characteristics of the final product These basic components include electronic and other compo nents Taking into account the objectives of the Low Voltage Direc tive such as basic components the safety of which can only to a very large extent be assessed taking into account how they are incorporated are not covered as such by the Directive In particular they must not be CE marked The Commission explains that only products and components that are ready to use and actually de facto operate may bear CE marking under the LVD There are a few cases however where CE marking is appropriate for components such as for those intended for building installations which include household switches lamps starters wires plugs fuses and some types of motors and transformers The EMC directive allows CE marking of components that 1 have an intrin sic function a
102. e fiwg standard s Validity ra Geir H rthe 62 CE MARKING HANDBOOK CERTIFICATE No P97555554 Order No SA Taiwan Export XX Taipei Taiwan Build in power supplies 12345XXX 5 2 5A 100 127 200 240V 50 60Hz Cl BRAND NAME SMITH DC O P 1 18A 5V 0 12A 3 3V 0 3A 12V 0 0 3A 12V 0 0 3A 5V 0 1 2A 5VFP where 5V amp 3 3V output 105W max and total power 145W max Dots in model name can be any alphanumeric character or blank and denpotes minor changes in SELV circuits or minor mechanical changes not affecting safety Safety std EN 60 950 1992 A1 A2 A3 A4 including possible listed national conditions deviations for Norway The certificate is valid until 1 November 2007 provided that all signed certification conditions are complied with and that possible changes to the product are notified to Nemko for acceptance prior to implementation The validity time may be reduced in case new standards are made applicable The certificate also applies as licence for use of Nemko s name and certification mark The above certified equipment compties with current technical standard s in Norway regarding safety as far as this can be checked Compliance with requirements regarding building in protection against electric shock and Electromagnetic Compatibility EMC must be checked when the equipment is built in a completed product or forms a part of a complete system It should be noted that by marketing of equipme
103. e of three layers of insulation passing the appropriate hi pot test 1 500 Vac for two layers Either the primary or the secondary wiring may be sleeved with an additional layer thereby achieving the total of three layers The primary wires are usually sleeved with solid tubing such as heat shrink or clear PVC Porous insulation and spiral wrap do not count as insulation since they typi cally fail the hi pot tests Adequate separation must also be maintained between wiring and exposed circuits such as exposed terminals on components or PCB traces Secondary wires contacting primary circuits on power supplies or primary wires contacting exposed secondaries are areas that must also meet the reinforced insulation requirements Where sleeving is used as supplementary insulation on internal wiring it must be positively retained in position and is considered as such if it can be removed only by breaking or cutting or if it is clamped at both ends 11 Grounding Reliability and proper identification are key to the protective earth PE in equipment Adequate sizing and the proper insulation colors of green with a yellow stripe shall be used for the PE safety and chassis ground wires Clear insulation on braids may also be used Green yellow is strictly reserved for the aforementioned grounds and may not be used for low voltage lt 50 V or EMC RFI grounds All accessible metal parts such as panels and doors providing guarding from hazardous volt
104. e that your product is not waylaid by unexpected regulations and approvals Informed consumers and consumer advocates also will be on the lookout for products As of this writing most of the legislation xii CE MARKING HANDBOOK and certification procedures are now in place and the goal of total harmonization is for all practical purposes complete Furthermore numerous product safety machinery and EMC standards have been published to support the directives essen tial requirements The standardization process is evolutionary with established pro cedures to cover all compliance aspects even where a standard is lacking or not yet formulated Knowing that no single book can cover all topics or products the scope of CE Marking Handbook A Practical Approach to Global Safety Certification is purposely limited to cover the subjects of most interest to equipment suppliers and consumers rights activists Concerns such as product safety requirements confor mity assessment procedures and enforcement are covered Electromagnetic compat ibility and machine hazards are also discussed within the body of this book in the final chapters CE Marking Handbook A Practical Approach to Global Safety Cer tification does not portend to cover all aspects of the topic at hand but endeavors to elucidate what is often confusing provide practical guidelines and dispel the myths surrounding CE marking Some people in industry feel that CE marking is jus
105. e to a new emphasis of strict liability on the man ufacturer s part Consumers can now initiate civil actions themselves without the need to prove negligence All producers involved in the production process are lia ble insofar as the finished product component or raw material they supply is defec tive The consumer can take simultaneous action against all parties involved in the supply chain Moreover the directive does not set any financial ceiling on the manu facturer s liability A questionable product may come to the attention of the enforcement authori ties by way of a customs inspection market surveillance audit user complaint com petitor or incident In any case the national enforcement authorities rely on either the harmonized standards or their national transposed standards to assess the suspect products conformity or lack thereof 78 CE MARKING HANDBOOK When a member state ascertains a product s nonconformity it may take appropriate measures Depending on the situation and nonconformity of the prod uct the manufacturer will then have to do one or more of the following with the product restrict or prohibit its sale make it comply withdraw it from the market or destroy it A domino effect then occurs The member state notifies the Commis sion which in turn notifies the other member states which then also take appro priate action Figure 5 1 shows the risks of non conformity Three examples illustrating enfor
106. ed in the light of the national criminal law applying in the case in question see Product Liability In addition to the enforcement provisions contained in 92 59 EEC on General Product Safety the primary directives Low Voltage EMC and Machinery direc tives clearly state that a member state may restrict a product s marketing or take other appropriate actions for any of the following reasons Failure to satisfy or nonconformance with standards European standards or Faulty application of standards misinterpretation or standard used has shortcomings or Failure to comply with good engineering practice or Product liable to endanger the safety of persons or Product does not comply with the protection requirements EMC or CE marking has been affixed unduly When a member state ascertains that a product does not comply with the requirements it may invoke the safeguard clause included in the directives and require the manufacturer to end the infringement under conditions imposed by the state The manufacturer agent shall be obliged to Restrict or prohibit the product s sale and or Make the product s comply and or Withdraw the product s from the market and or Destroy the product s Measures taken by the authorities shall be addressed as appropriate to Producer Distributors and or party responsible for the first stage of distribution within their limits of activities and Any other person where necessary
107. ed on the new approach and global approach will include a chapter on the marking clarifying its role Does this development constitute a real danger to the internal mar ket bearing in mind that the EC marking is intended to eliminate technical barriers to trade No It is true that the Community harmonization Directives which provide for the affixing of the marking aimed to remove technical barriers to trade and has as their objective the establishment and functioning of the single market y However the free circulation of goods which is assured by the marking does not necessarily mean that people will buy the products In order to market and sell a product successfully a manufacturer often has to do more than what is required by legislation 39 This Page Intentionally Left Blank CHAPTER 3 Standards The Technical Rules Better to ask twice than lose your way once DANISH PROVERB Harmonized Standards Presumption of Conformity Standards in Europe date back to the late 1800s The International Electro technical Commission IEC was founded in 1906 to establish safety specifica tions for energy and electrical products and protect consumers and the environment IEC standards are prepared with consultation from technical com mittees TC in over forty countries These committees have representation from many interested parties including but not limited to manufacturers authorities notified bodies and consumer groups A
108. edy of life is when adults are afraid of the light Pato ca 400 B C Focus on Standards The goal of the CE Marking Handbook A Practical Approach to Global Safety Certification is to increase everyone s awareness of the real meaning of the CE marking and the importance of producing safe products The myths and realities of European Conformity have been presented and with this knowledge manufactur ers exporters and consumers can make sound decisions If this is your first experience with European Conformity CE or even if you have been working in the field for some time understanding the rules may have seemed like an insurmountable task With all the misinformation and confusion sur rounding the CE marking this attitude is certainly reasonable but I hope you now have a better understanding of the real meaning of the CE marking and the technical rules for safe product design and the required assessment procedures that ensure product conformity Focus on standards to attain the presumption of conformity for your products p Directives tell us why we must comply consumer safety EMC and what may happen if we ignore the laws withdraw products But it s the European standards that show us how to comply design and assessment CE s Credibility at Risk Evidence to date leaves the credibility of the CE marking in doubt Based on my numerous safety EMC inspections of equipment gt 75 fail and seeing 135 136 CE MARKING H
109. een and yellow of the incoming supply Other grounds may not be placed on the same ground terminal as the PE conductor To avoid confusion light blue is reserved for neutral Green and yellow is for safety and PE ground only and shall not be used for low voltage lt 50V or EMC RFI grounds The wiring terminals shall be appropriately and plainly marked and corre spond with the circuit diagrams Terminals shall be of a IEC type which means touch safe All connections must be double fixed to secure them from accidental loosening especially the protective earth conductor Placing two or more wires into one terminal is permitted only in the cases where the terminal is designed and tested for that purpose Terminal blocks shall be so mounted that wiring does not cross over the terminals Selecting an EU type approved terminal block is the best option to ensure conformity without further testing Wire splicing is prohibited and U S wire nuts are not allowed as they do not meet the IEC requirements for wire connections They are not considered as a reliable termination means e g not ade quate in securement identifiable fixed from moving oe U S style twist wire nuts do not meet the EU requirements and shall not be used l Access Areas Operator access area is any area to which under nor mal operating conditions access can be gained without the aid of a tool e g by a person s hand or fingers alone Opening a hinged door or r
110. ements and this leaves it up to the market forces to set their own expectations In doing so the manufacturer has a choice of meeting the minimum legal requirements ERs or meeting the market expectations as well In Europe expectations vary consider ably between countries Even with self declaration the demand for third party certification and marks is unlikely to go away especially in the more regulated countries like Germany and Scandinavia Certification and marks may be a mar keting requirement like ISO 9000 because of the greater awareness of standards among consumers at all levels in the European Union Successful product mar keting requires an awareness and desire to meet the customer s expectations The customer knows that buying products bearing reputable third party marks such as VDE or TUV approval marks ensures that the product is not only in accor dance with the European directives and standards but also is suitable for its purpose and above all safe 2 Note See Chapter 6 for product safety technical requirements Chapter 4 for safety verification and Chapter 7 for the definition of safety 82 CE MARKING HANDBOOK WE NEED ANEW PLAN WELLWE CALD phop TUESE Anp A QUALITY PRODACT LIABLITY Teac THAT S wil WAU nN ml II AUG 9 FIGURE 5 2 We need a plan CHAPTER 6 Design Guide for Safety Conformity It is not who is right but what is right that is important THomMas HUXLEY Introduction E
111. emoving a cover by hand without a tool makes the area behind the door panel an operator access area and all hazards shall be adequately guarded or interlocked to remove the hazards before access Fixing the door or cover in place with screws is one way of protecting persons but if door or cover interlock switches are used to reduce a hazard high voltage moving parts etc they must be of a fail safe type and nonoverridable by the standard test finger The nonsafety type that may be activated ON OFF by a person s finger through a push action and or pulled into a locked ON position is not permitted In addition the restoration of the interlock shall not initiate machine motion or operation if this could give rise to a hazardous condition v Machine builders sometimes forget that tops and bottoms may be necessary on the equipment to keep persons and foreign objects out and to minimize the spread of fire from within Design Guide for Safety Conformity 121 J Enclosures Selecting an electrical control enclosure that meets all of the relevant requirements is one of the problems facing machine manufacturers Enclosures must be mounted to facilitate accessibility and maintenance and pro tected against external influences under normal use conditions This can be accomplished only if the enclosure meets the EU standards and is used properly in the equipment EN 60204 1 EN 60529 and other standards are very specific con cerning the enclosures
112. ented in this chapter A complete assessment according to all relevant stan dards must be performed by qualified persons to ensure conformity 83 84 CE MARKING HANDBOOK The terms product and equipment are interchangeable and include machinery Operator user and consumer are also equivalent terms The term appliance is gen erally applied to household and similar products and includes commercial appli ances I must caution you that even when a product complies with these design tips the product may not necessarily conform to all aspects of the standards Proper application of the guidelines in this chapter along with the standards will better ensure that the product complies with European and international safety stan dards EN TEC The design guide in this chapter is for product machine and system designers It does not cover testing or assessment of individual components e g built in components Component standards exist to evaluate such components and should be referred to when necessary This guide stresses the importance of selecting compo nents that have visible European approval marks such as TUV or VDE as positive evi dence of compliance in lieu of testing each component for which no evidence exists Some component standards are found in the Low Voltage Directive LVD and their conformity is mandated by the Low Voltage and General Product Safety Directive CE markings are not allowed for most components and where fou
113. enterpiece of the total harmonization process Figure 3 2 At the beginning of this chapter we mentioned the importance of using the proper European standards during the design phase in anticipation of the final conformity assessment The first attempt at compliance usually assessment of an existing product will be a challenge but after the first success the designer will be surprised at the amount of knowledge and understanding gained The safety and EMC concepts learned can be utilized during future design phases thereby ensuring successful testing and assessment to garner CE marking to all new products Compliance with European standards is defined as the minimum acceptable criteria and the manufacturer may have to go beyond the standards such as complying with the EU laws directives and meeting market expectations The General Product Safety Directive 92 59 EEC E The purpose of the provisions of this directive is to ensure that products placed on the market are safe e Where there are no specific Community provisions governing the safety of the prod ucts in question a product shall be deemed safe when it conforms to the specific rules of national law of the member state in whose territory the product is in circulation e In the absence of specific rules as referred to in paragraph 1 above the conformity of a product to the general safety requirement shall be assessed having regard to voluntary national
114. equiring man datory action Mandatory No specific For general initiation Start On preferred of functions except Stop Off emergency stop see Start On also note Stop Off Start On Stop Off preferred meaning assigned Note Where a supplemental means of coding e g texture shape position is used for the indentit fication of push button actuators then the same color White Grey or Black may be used for various functions e g White for Start On and Stop Off actuators FIGURE 6 8 Push Button Colors and Their Meanings assemblies shall be plainly identified with the same symbols as shown in the techni cal documentation Figure 6 10 The item designations are generally assigned when the circuit diagram is drawn The designations are located adjacent to the items and on or adjacent to terminals not on replaceable components The item designation markings labels etc shall be permanent and visible after the components and wir ing are in place The item letter codes and methods for establishing these designa tions are recommended in IEC 750 and EN 61346 1 2 An item designation is a distinctive code that serves to identify an item in a diagram list chart and on the equipment A basic part is one piece or several pieces joined together that cannot normally be disassembled without destroying its function such as an integrated circuit or resistor A subassembly is two or m
115. es are identified with the year and identifier number such as 85 375 EEC for the Product Liability Directive which was pub lished in the Official Journal on August 7 1985 Most directives are adopted at a later date within a specified time limit For example article 19 of the Product Lia bility Directive 85 375 EEC states that this directive must be brought into force by the member states within three years The directives typically apply to e Member states e Manufacturers Certification and standards bodies Importers dealers and users As of this writing there are over seventeen generic and product specific direc tives as well as other important basic directives Figure 2 1 shows the directives for the New Approach to date Here is an overview of the three types of directives Basic directives type A The basic directives apply to all manufacturers of products and address trade enforcement liability and other issues It is important to understand the implication of these directives especially con cerning enforcement against product manufacturers Examples of the basic directives are CE Marking Conformity Assessment General Product Safety and Product Liability Products components and materials not covered by Type B or C directives must still be safe according to the General Product Safety Directive e g comply with standards 15 16 CE MARKING HANDBOOK Directive CE in force Low voltage directive LVD
116. es authority to control the safety of products and take the appropriate measures Sets up a system of rapid exchange of information on defective products at national and Community levels Information is passed to all member states and possible publishing in the Official Journal negative PR Product Liability Directive 85 374 EEC To better protect the consumer strict liability American style law now applies to producers importers or distributors of any material component product machine etc A product is con sidered defective if it does not provide the safety a person is entitled to expect The consumer may initiate actions against all parties involved in the supply chain The injured person has only to show a casual relationship between the defect and the damage and the producer importer may be assumed guilty CE Marking Amendment 93 68 EEC Where a member state or competent authority establishes that the CE marking has been affixed unduly the manufacturer or their agent established within the Community market shall be obliged to make the product equipment comply as regards the provisions concerning the CE marking and to end the infringement under conditions imposed by the member state Where noncompliance continues the member state must take all appropriate measures to restrict or prohibit the placing on the market of the product equipment in question or to ensure it is with drawn from the market Lohbeck
117. es set out in the European standards is the minimum criterion and most manufacturers should not only meet but also endeavor to exceed these requirements Even when the product conforms to the relevant standards the authorities are not barred from taking the appropriate actions against manufactur ers where there is evidence that a product is dangerous see General Product Safety in Chapter 2 Standards The Technical Rules 43 The Low Voltage Directive LVD 73 23 EEC Products are presumed to conform to these objectives ERs where the equipment has been manufactured in accordance with technical standards which in their order laid down in the directive are as follows harmonized standards drawn up in accordance with Article 5 where harmonized standards have not been drawn up and published interna tional rules IEC etc where harmonized standards or safety provisions are not yet in existence the national standards in force in the Member State of manufacture Article 7 C59 p 3 Whereas Decision 90 683 EEC establishes the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives whereas the choice of procedures must not lead to a lowering of safety standards of electrical equipment which have already been established throughout the Community 93 68 EEC No L220 p 21 The EC declara
118. etic on ener _ emniter ne nae pine wing toad Transducers from nonelectrical Thermoelectric sensor thermo cell photoelectric to electrical quantity or vice cell dynamometer crystal transducer microphone pick up oe apace Binary elements delay devices Digital I C s and devices delay line bistable ele storage devices ment monostable element core storage register magnetic tape recorder disk recorder Miscellaneous Lighting device heating device device not specified elsewhere in this table Protective devices Fuse overvoltage discharge device arrester Rotating generator rotating frequency converter bat tery oscillator quartz oscillator Optical indicator acoustical indicator Relays contactors Inductors reactors Induction coil line trap reactors shunt and series Measuring equipment testing Indicating recording and integrating measuring devices signal generator clock Switching devices for power cir Circuit breaker disconnector isolator Adjustable resistor potentiometer rheostat shunt Switching device for control cir Control switch push button limit switch selector T Voltage transformer current transformer U Modulators changers Discriminator demodulator frequency changer coder inverter converter telegraph translator V Tubes semiconductors Electronic tube gas discharge tube diode transistor thyristor Transmission paths Conductor cable busbar wa
119. etween the primary circuits and accessible conductive parts and measure the resistance of the protective earth circuit There are two production safety tests required for most products 1 Electric Strength Test 2 Ground Continuity Test The electric strength test hi pot consists of applying to the equipment a sinu soidal AC voltage or an equivalent DC voltage i e 1 500 Vac or 2 121 Vdc between the primary and ground for 1 to 2 seconds depending on the product stan Design Guide for Safety Conformity 115 dard The tolerance of the voltage shall be 100 V 0 V No insulation breakdown shall occur during the test An insulation breakdown is defined as any increase from the steady state current measured during the test The ground continuity test is carried out by circulating a test current of not more than 25 A typical for machines or 1 5 times the current capacity of the prod uct i e 1 5 times the fuse breaker rating for the time required to obtain a mean ingful reading through the parts to be tested and the ground PE terminal e g between any user touchable metal parts and the earth ground The power supply cord shall not be included in the measurement All test results shall be kept available with the choice of support and format left to the manufacturer separate forms or lists of equipment or grouped according to the most suitable parameters are equally acceptable For all products manufac tured and tested the followi
120. evant Euro pean Standards EN where such exist In absence of European Standards compliance shall be to available International Standards IEC 4 2 FIGURE 6 1 Product Standards Require Component Safety Compliance Design Guide for Safety Conformity 93 2 Component Selection and Conformity Verification If a critical or safety component does not have the proper approval mark the test and certification body may fail the product or require testing of the component Manufacturers doing a self assessment of their equipment should use the same crite ria as the EU bodies and select only components that they know have been tested certified and bear an EU approval mark Anything less may require additional test ing and or review by a European component expert See Figure 6 2 for component acceptance criteria Because of the almost universal acceptance of the European standards EN and IEC around the world many suppliers now offer components that are EU type approved in addition to the U S recognition The U S is also moving toward accep tance of the European product standards Unfortunately at this time U S and EU product and component standards are different The United States focuses on fire hazards and materials whereas Europe stresses shock hazards and construction Because of these and other substantial safety differences component suppliers real ize the need for dual approvals to satisfy both the U S and Intern
121. evel see Approval Marks above Advantages EU notified bodies may accept CB Certificate for issuance of notified body Approval Mark above Some non European NCBs participate in CB Scheme for their national approval Test report in CB format TRF CB Certificate all ENs and ERs for the CE marking requirements and expe dite Approval Marks product manufacturers should use a national certification body NCB that is also a European notified body in OJEC Additional test samples and subsequent testing may also be reduced or elimi nated for Approval submittal e No visible Approval Mark on product with only CB Cert e Additional test samples may be required for national Approval submittal CB Certificates shall not be used in any form of advertising or sales promotion References IEC standards and may not address EN standards for the CE marking e May not address all ERs of the directives Limited to product tested by S N European harmonized standards EN listed in the Official Journal shall be used for CE confor mity verification 2 In all cases the CE marking declaration of conformity and technical file are required 3 The CE marking is not a mark and should not be confused with a mark certificate or approval issued by a European recognized third party e g notified or competent body The CE marking is a
122. f fails to hold when the cord is pulled 10 Insulation and Separation of Circuits Insulation separates live parts of the product from the user and prevents live parts from coming into contact with each other For protection against direct and indirect contact with live parts insulation is safer than grounding or fusing The pro tective measures are shown in the relative product standards and apply to all prod ucts and machines The types of insulation applied between circuits of different potentials and metal parts depend on the equipment class possible faults and the parts in question The voltage and part or circuit accessibility are also important for proper selection of the insulation type such as double or reinforced insulation between live parts and user accessible parts Basic insulation is required between live parts and grounded metal parts There are five types of insulation Basic supplementary and reinforced insu lation are most often applied for safety purposes Operational insulation Insulation needed for the correct operation of the equipment such as lacquers or circuit board coatings Operational insula tion does not protect against electrical shock Basic insulation Insulation to provide basic protection one level against electrical shock Supplementary insulation An independent insulation applied in addition to basic to ensure protection against electric shock in the event of a failure of the basic
123. five wire or other Rating label Company model number voltage amperage and frequency IEC sym bols visible durable next to input date code machines other Markings On Off symbols fuses outlets col ors of indicators lights and buttons other Machinery E stop function and controls other 8 ji Single fault and abnormal tests Short open nonapproved critical components xfmr outputs blocked vent others Test results attached A ES 9 Wiring V and A rating size UL insulation fixed cord lt HAR gt grn yel safety dbl fixed terms 600 V for primary or 300 V w sleeving Machinery ident by colors or numbers Power inlet module or fixed cord lt HAR gt IEC strain relief IEC terminals touchsafe L N PE markings double fixing other Design Guide for Safety Conformity 131 Directive s Standard s The Safety Company Checklist No Clause Requirements Comments v 10 PCB transformer insulation rein forced prim sec basic prim grd other Wire separation prim sec distance or thickness 2 layers or 3 layers or other 11 PE ground is isolated connection secure and PE ground symbol adja cent to stud PE symbol one other grounds metal encl grd d grn yel wire for safety grd s other Power disconnect Double pole switch circ brkr cord plug
124. forcement 81 other member state authorities to increase enforcement efforts throughout Europe v Over 50 of 3 000 machines inspected in Sweden failed to com ply with documentation and labeling rules The authorities were only performing administration checks for the CE marking declaration of conformity and manuals this time more to come Legal Requirements and Market Demands The European Commission s goal of single market access is virtually a real ity for companies who follow the New Approach rules Technical requirements standards and laws essential requirements exist for the most part to protect the public from interference EMC and dangerous occurrences safety caused by prod ucts The CE marking is a symbol of the manufacturer s self declaration to indicate conformity with the minimum requirements allows products to be placed on the market and ensures the free movement of goods BA Keep in mind that the CE marking is not intended to be a sales or marketing tool for if all products have the CE marking what places one product above another In the past enforcement was at best spotty but now with the New Approach everyone is becoming aware of the requirements manufacturers buy ers competitors and inspectors alike The CE marking is primarily for market control by customs inspectors and enforcement authorities but customers may expect more The Commission has laid down the minimum requir
125. form to the relevant standards Failure is most likely when nonapproved components are used Since the 1970s Old Approach a self declaration according to the LVD was possible but most components carrying only a manufacturer s declaration failed when tested by a European body Under the New Approach nothing has changed Safety and criti cal components still must comply with the standards but those that have only the Design Guide for Safety Conformity 91 manufacturer s self declaration and CE marking and lack type approval markings usually fail testing by a EU body eo Because of misinterpretation or misapplication of the standards nonconformity of component safety is commonplace even when tested by the component manufacturer according to an EN or IEC standard Most nonapproved components fail safety tests by European testing and certification bodies The equipment manufacturer takes complete responsibility for the end product or machine and the components it specifies If no positive evidence exists CE not considered it is always prudent to perform ail relevant component tests or select a different component so no questions arise see Figure 6 1 Safety testing and certifi cation of components should rest with the component manufacturer and not burden the company that purchases them instead leaving it up to the product designer to only verify through positive evidence that the component complies with the rele vant standard
126. formity design guidance 88 133 circuit and thermal protection 107 8 component safety and liability 89 92 component selection 93 95 conformity verification 93 95 constructional data forms CDF 95 98 electrical safety testing 112 14 equipment classification 98 99 flammability of materials 111 12 grounding 106 7 indicators 100 101 input wiring terminations and identification 103 5 instructions 110 11 Index 153 insulation 105 6 languages 110 11 markings 100 101 miscellaneous requirements for machinery 115 33 power consumption 99 power disconnect 107 production tests 114 15 rating labels 100 separation of circuits 105 6 single fault concept 101 3 stability and mechanical hazards 108 10 warnings 110 11 Safety conformity design guide for 83 133 electrical safety for products and machines 83 85 principles of safety 85 87 Safety mindset and quality 75 76 Safety testing electrical 112 14 U S 74 Safety EMC 4 10 11 compliance 29 conformity 58 consumer 6 laws 7 Sales and CE marking 66 Self declaration 29 30 Self test 136 37 SELV Safety Extra Low Voltage 86 87 98 Service access area 87 personnel 87 116 Shock and construction 71 72 electric 86 hazards 70 71 and construction 12 Single fault concept 87 101 3 defined 101 2 Single market access 81 Sleeving 106 Socket types in Europe 103 4 154 CE MARKING HANDBOOK Sources information 145 46 Standards 41
127. forms types A B and C otherwise called basic generic and product specific standards The type C product specific standards are the top level standards and take precedence over types A and B stan dards Refer to the appropriate standards as needed 48 CE MARKING HANDBOOK Basic standards type A These fundamental standards contain general prin ciples for safe design or measurement techniques levels for EMC and may be applied to products when appropriate The A and B standards are especially important for EMC and machinery Some examples of basic safety standards for machinery are EN 292 1 2 Design Concepts and EN 1050 Risk Assessment The EN 61000 4 X series IEC 801 X for immunity levels is an example of basic standards for EMC Generic standards type B For safety the type B standards concern specific technical aspects and are applied as needed such as for specific components or guard ing For machinery the B standards are further divided into B1 and B2 standards B1 Standards These apply to particular aspects such as surface temperatures and safety distances Some B1 examples are EN 418 Emergency Stop Systems EN 954 1 Safety Related Control Systems and EN 60204 1 Electrical Require ments of Machinery B2 Standards These apply to particular safety devices or components such as EN 574 Two Hand Controls and EN 60947 Safety Switching Devices For EMC the generic standards are grouped by function and environment
128. he European Communities OJEC and transposed into national standards are presumed to conform to the essential require ments of the directives When considering standards for a product safety assessment the appropriate standards shall be applied They are listed in order of preference 1 A European harmonized standard EN published in the Official Journal 2 An IEC standard that has been published in the relevant directive s when a EN does not exist 3 When a harmonized EN or IEC does not exist a EU national standard and 4 Codes of practice recognized within the Community where no EN IEC or national standard exists The question of using U S standards for EU compliance always arises Because there are numerous technical differences between the two countries stan dards and the U S standards are not listed in the OJEC these standards may not be considered for European conformity Also there are major differences in philosophy between the European Union and United States The U S focus is primarily on flammability and testing whereas the EU focus is on shock hazards and con struction Although both the U S and EU safety experts consider the same safety aspects and tests it is with a different emphasis This often means the difference Europe s Approach to Total Harmonization 13 between passing and failing U S standards are not equivalent or comparable to the EU harmonized standards The EU sta
129. he manufacturer or their agent within the Community Member states must take all provisions of national law to exclude any possibility of confu sion and prevent abuse of the CE marking and Where a member state establishes that the CE marking has been affixed unduly the manufac turer agent or supplier is obliged to make the product comply and end the infringement under conditions imposed by the state and where noncompliance continues the member state must restrict prohibit or withdraw the product s from the market What the CE marking is Is a manufacturer s or agent s self declaration a do it yourself approach Is a symbol of a products conformity to the essential requirements of the directives Allows products to be placed on the market and ensure free movement of goods Indicates manufacturer has undergone all the relevant procedures Presumption of conformity is assumed for customs inspectors only when products are in conformity with European harmonized standards ENs Is for inspectors checks to facilitate controls on the Community market and Is for finished products such as equipment machinery systems apparatus and devices that are complete and ready for use by the operator as a single commercial unit Not for sales marketing or promotion Not a mark certification or approval from European recognized third party e g notified body Not a quality marking to influe
130. heat during a locked rotor or run ning overload test Transformers and motors are often not protected by the primary fuse and overheat with a fault in the secondary Fuses in the secondary or built in thermal devices or both may be required to limit the hazards as a result of faults Some standards require the use of temperature limiters in any case These devices are considered critical to safety Always specify a properly rated device that is suitable for its application and make sure they are European type approved to ensure they meet all applicable standards for safety and reliability 14 Stability and Mechanical Hazards Under conditions of normal use products shall remain physically stable to the degree that they cannot present a hazard to operators or service personnel The various tilt and tip tests are not applicable for equipment that is intended to be secured to the building before operation as specified in the installation instructions When stabilizing means are provided to improve stability when doors or drawers are opened they must be automatic If not automatic suitable and conspicuous markings shall be provided to caution service personnel The physical requirements depend on the applicable product standard Many standards are available for machine guarding and protection ITE standard EN 60950 gives a good description Design Guide for Safety Conformity 109 of the enclosure tests for stability and mechanical hazards and
131. hey want to buy the best and are willing to pay for it Selling products in Germany takes much more than a sales pitch Other than Scandinavia no other country has a more regulated and formalized system of showing conformity to the technical rules These rules have not been erected to keep products out but in the case of Germany are an inherent part of their historical situation and structure The standards and rules they have set concerning design safety and reliability have served as a benchmarks in other markets The German safety EMC laws and standards have become models for the new European directives and harmonized standards Furthermore the German national laws and standards are now in line with Europe s and vice versa Consumer expectations vary considerably within Europe To illustrate this point there was a saying that described the differing attitudes between the United Kingdom and Germany In Germany everything is forbidden except that which is permitted In England everything is permitted except that which is forbidden This is obviously an overgeneralization but nevertheless the principles are accu rate The United Kingdom has a long tradition of self certification whereas third party certification has been quite common in Germany even though not mandatory by law for most products In Germany certification for many products is voluntary but the need for a product to certified by a reputable third party one they kn
132. hinery Directive applies to your equipment identify the appropriate product or machine safety standard first It is then easy to know which safety directive applies since product standards are usually listed under only one of the directives 18 CE MARKING HANDBOOK Some of the basic directives type A that apply to most product and machine suppliers are e General Product Safety Directive 92 59 EEC e Product Liability Directive 85 374 EEC Conformity Assessment Procedures and CE Marking Rules 93 465 EEC e CE Marking Amendment 93 68 EEC General Product Safety Protection and Safeguards The General Product Safety Directive 92 59 EEC requires product manu facturers and suppliers to place only safe products on the market and to ensure a high level of protection of safety and health of persons The directive also gives member states authority to establish national enforcement authori ties Authorities have the power to monitor product compliance or lack thereof take appropriate measures and impose suitable penalties When neces sary the member states shall immediately and efficiently organize the removal of dangerous products from the market and inform the Commission of the restric tion or withdrawal If justified the Commission then notifies the other member states who also take appropriate actions When necessary the Commission informs consumers of the risks posed by the dangerous product s The seve
133. ication equipment 98 99 Clause safeguard 21 Colors wire 104 5 Compliance with European standards defined 50 safety EMC 29 Components defined 4 89 fault tolerant 117 18 parts list 95 98 passing tests 95 prequalified safety sensitive 92 principles 85 safety and liability 89 92 selection 93 95 Conformity assessment 45 procedures 27 31 declaration of 5 33 definitions 138 40 evaluation of 5 evidence of 136 presumption of 4 8 11 41 46 67 of products 85 safety 83 133 standards versus directives for 11 13 verification 93 95 Construction files 5 principles 85 and shock 71 72 shock hazards and 12 Consultants benefits and limitations of 68 69 Consumer expectations European 75 Consumer safety EMC 6 Consumption power 99 Control reliable defined 103 Controls border 26 27 Cords power 104 Criterion minimum 42 minimum acceptable 46 49 Customs authorities 26 27 D Declaration of conformity 33 defined 5 Defectiveness product 24 Defense of due diligence 3 57 63 Definitions European Conformity 138 40 Differences EU and U S 69 75 Diligence defense of due See Due diligence defense of DIN Deutsches Institute for Normen 7 Directives basic 15 defined 4 6 138 Electromagnetic Compatibility EMC 16 17 General Product Safety 18 22 generic 16 and implementation of European laws 9 Low Voltage LVD 84 85 89 90 Machinery 11 17 115 New Approach 35
134. ich includes NAMAS Great Britain RNE France and others Originally conceived as a government tool for consumer protec tion the idea of accredited notified bodies and product certifications has received fresh impetus from the European Commission and many trade organizations Notification is the formal recognition of a testing and or certification body by the European Commission After a successful laboratory assessment and recognition by an accreditor the state government notifies the Commission of the nationally accredited body The accredited bodies are then listed in the OJEC as Bodies Noti fied to the Commission and to the Member States commonly referred to as notified bodies or third parties Testing and certification bodies third parties must be qualified to an equal standard EN 45000 and other criteria if mutual recognition agreements MRA are to function e g recognition of test reports certificates approvals The aim is to ensure that accredited bodies operate in a comparable manner to build a solid foun dation for confidence The goal of accreditation is to ensure that recognized test methods are followed with verification achieved through mutual audits The proce dure ensures consistency and hence promotes greater competence and quality in testing and certification in the Community This network of national networks is the most efficient means of achieving trust among all parties L The notified bodies primary
135. iderable extent If it is necessary to avoid hazards when operating installing maintaining transporting or storing equip ment safety information shall be provided by the manufacturer in the form of warn ing symbols on the product along with instructions in the product documentation Maintenance instructions are normally made available only to service personnel For pluggable equipment intended for user installation operating and installation instruc tions shall be made available to the user Some of the common warnings are e CAUTION Doubie pole neutral fusing Disconnect power before servicing e CAUTION This unit has two power cords Remove both cords to discon nect power e CAUTION High leakage current Earth connection essential before con necting supply for stationary equipment e CAUTION See installation instructions before connecting to the supply for equipment intended for connection to multiple rated voltages or fre quencies unless means of adjustment is simple e CAUTION Danger of explosion if battery is incorrectly replaced Replace only with the same or equivalent type recommended by the manufacturer Dispose of used batteries according to the manufacturer s instructions if product is provided with a replaceable lithium battery e CAUTION Plug on power cord is disconnect device The wail s socket outlet shall be installed near the product and easily accessible for plugga ble equipment withou
136. ies the manufacturer s obliga tions for assessment procedures and the CE marking The CE marking is used by enforcement authorities to facilitate controls on the market Products may be placed on the market only after conformity assessment according to the applicable require ments directives standards etc and after the manufacturer has affixed the CE marking see Figure 2 5 28 CE MARKING HANDBOOK The objective of a conformity assessment procedure is to give users consum ers and authorities assurance that products conform to the various require ments as expressed in the directives e Conformity assessment can be subdivided into modules to control the design phase or the production phase in certain cases these two functions are inseparable e g modules A G and H e A product should undergo a control in both phases before being placed on the market if the results are positive The directives shall set out the range of possible choices which can be considered which may be considered by the Council to give the authorities the acceptable level of safety they seek for a given product or product sector In setting the range of choices open to the manufacturer the directives will take into consideration such issues as the appropriateness of the modules to the type of products the nature of risks involved the existence or non existence of third par ties the types and importance of production etc The directives
137. ieve the high level of safety the consumer requires Conclusion 141 A Test Report and Approval Mark from a highly reputable European testing and certification body builds consumer confidence in the equipment s safety EMC and quality To adequately protect the consumer and manufacturer this safety EMC certification and approval marking philosophy should be applied to all equipment categories including components products and machinery Manufacturer s whose equipment truly meet the goals of European Conformity will pass the final test as marketable and approved Opinions are free of charge but facts take charge Davip LOHBECK This Page Intentionally Left Blank Appendix A European Safety and EMC Acronyms AIMD BG CB CCA CCB CD CE CEN CENELEC CERT DIS DOA DOP DOR DOW E EC ECB EEA EEC EFTA EHSR EMC EMCD EMD prEN EN prENV ENV EOTC Active Implantable Medical Devices Directive Berufsgenossenschaften Trade Cooperative Association Certification Body CENELEC Certification Agreement Committee of Certification Bodies Committee Draft Conformite Europeene European Conformity CE Marking European Committee for Standardization European Committee for Electrotechnical Standardization EC Certificate of Conformity by Notified Body Draft International Standard Date of Announcement EN standards Date of Publication EN standards Date of Ratification Implementation EN s
138. ified body approval mark certification or test report con noting a higher level of quality to ensure safety EMC compliance To control non conforming products the following clause from the Official Journal of the European Communities OJEC applies A single CE marking should be used in order to facilitate controls on the Community market by inspectors and clarify the obligations of eco nomic operators manufacturer or supplier the aim of the CE marking is to symbolize the conformity of a product and to indicate that the economic operator has undergone all the evaluation procedures laid down by Community law in respect of his product OJEC 93 465 EEC The main goals of the CE marking are to Indicate a product s conformity to the essential requirements of the directives Allow products be placed on the market Ensure the free movement of goods and e Permit the withdrawal of non conforming products by customs and enforcement authorities It is well advised that manufacturers and suppliers be informed not only of the CE marking s advantages but also of its limitations The CE marking e Is not a mark or certification or approval issued by a third party e Is not for sales or marketing or promotion e Is not a quality mark and e Is not for components although there are some exceptions the vast majority of components do not need CE marking see Design Guide Components in
139. ifying European type approved and marked components proves to be the path of least resistance and the lowest cost alternative 92 CE MARKING HANDBOOK To ensure safety compliance and limit testing end product manufacturers often demand prequalified safety sensitive components with EU type approval marks VDE TUV These component marks help to ensure compliance with stan dards and reduce testing Components with VDE TUV marks need only be checked for proper application and use in the product European approved components may cost a little more but they are usually more reliable and in the long run will save the product designer much aggravation and time Figure 6 1 shows some of the stan dards that require components safety compliance EN 60950 IEC 950 Safety of Information Technology Equipment Where safety is involved components shall comply either with the requirements of this standard or with the relevant IEC component standards 1 5 1 Evaluation and testing of components shall be carried out as follows a component certified by a recognized testing authority for compliance with a stan dard harmonized with the relevant IEC component standard shall be checked for correct application and use in accordance with its rating It shall be checked to the applicable tests of this standard as part of the equipment with the exception of those tests which are part of the relevant IEC component standard a component which is not
140. in developing marketing strategies for the European mar ket the most asked question is What do I need to sell products in Europe In this case product reliability verified safety and quality become paramount since meeting these criteria are what is needed to gain consumer acceptance The CE marking does not guarantee these factors So need really depends on your perspec tive that is whether you are trying to just ship the product or to sell the product As stated by Mr Bangemann VP of the European Commission The CE marking is not a quality marking although it is often wrongly perceived as such and then com pared to other quality marks Quality markings approval marks as opposed to the CE marking are voluntary address consumers or users and tend to influence their appreciation toward the relevant product CE Marking Handbook A Practical Approach to Global Safety Certification is a guide to understanding the why s and how to s of meeting European requirements for CE marking The why s or reasoning are explained in the laws known as direc tives and the how to s or product requirements are explained in the technical rules known as harmonized standards The directives and standards must be considered together with a focus on standards for the product s design and assessment criteria xiv CE MARKING HANDBOOK The most important consideration must be on protecting the consumer user opera tor buyer et
141. insulation equals two levels Double insulation Insulation comprised of both basic and supplementary insulation provides two levels Reinforced insulation A single insulation system that provides a degree of protection against electrical shock equivalent to double insulation It may comprise several layers to meet thickness and or test requirements Separation of the internal wiring such as between primary and secondary wires or adequate thickness or layers of insulation is required even within the equipment Whenever possible it is best to physically separate all primary and sec ondary wires so that there is no possibility of their coming into contact with each other When this is not possible as when primary and secondary wires touch care must be taken to ensure that the proper insulation level reinforced is maintained As a general rule when primary and secondary wiring touch only two layers of 106 CE MARKING HANDBOOK insulation is required one on each wire if one layer has a minimum thickness of 0 4 mm and the other wires insulation passes a hi pot test 1 500 Vac To obtain reinforced with only two layers of insulation one on each wire it is best to use 600 V rated insulation 0 7 mm thickness for the primary wires since 300 V wire insulation has typically less than the required 0 4 mm thickness Whenever the min imum 0 4 mm thickness requirement is not met reinforced insulation may be accomplished with the us
142. insulation thermal limiter cutout and secondary fusing missing Protective devices are recommended or mandatory in some cases for effective protection against overloading and short circuits EN 60204 1 requires the use of a contro transformer on machines with more than five electromagnetic coils The transformer must be installed after the mains switch to ensure isolation Small transformers are not typically suited for control circuits since they are designed for simple resistive loads Overcurrent protection is required in accordance with standards EN 60742 60204 1 IEC 76 5 The type and setting of the overcurrent device should also be in accordance with the recommen dations of the transformer supplier The preferred secondary voltages are 24 48 115 230 V 50 60 Hz Fault free operation must be verified prior to using lower voltages F Motors Motors like transformers are another problem facing machine builders Various standards specify construction and overload protection requirements for motors EN 60034 60742 60664 60204 1 Motors must meet the requirements for dimensions construction insulation class connection overload protection ingress protection markings abnormal testing and other parameters Design Guide for Safety Conformity 119 Effective motor protection is crucial and achieved by using overload protection devices temperature sensing devices and current limiting devices The protection devices shall protect mo
143. ircuits and components guarding electrical mechanical radiation chemicals gases documentation and testing Design Guide for Safety Conformity 129 Safety Checklist Directive s Standard s The Safety Company Checklist Requirements Comments Critical components comply with EN IEC component standards and verified by Approval marks certificates other See 2 and 3 Components conformity verification Approval marks visible on compo nents Certificates and reports available upon request Restrictions for use complied with per certificate Components needing additional IEC confirmation Transformer motor other Checked by submittal testing other 3 Constructional Data Forms CDF complete Manufacturer part number and rat ing verified Approval mark s shown on CDF not CE or IEC Certificates on file Attach Constructional Data Form s 4 Equipment shock classification Class I Class II Class II Equipment mobility classification Hand held movable stationary fixed 130 CE MARKING HANDBOOK The Safety Company Product Directive s Standard s Eng Model No Date Serial No Comments lv Requirements Input power meas VAC A _ Hz or VDC __ mA or for three phase 3 PEN AC 400 V__ A 50 Hz four wire or 3 N PE AC 400 V___ A 50 Hz
144. ird party manufacturers Figure 2 3 describes the product liability terms The definition of supplier has been broadened and now includes retail traders who may be subject to the secondary liability of the supplier Where several persons are liable for the same damage the injured person should be able to claim full com pensation for the damage from any one of them A major increase in the liability of the so called quasi producers is now possible These companies which do not tradi tionally produce products but only select or distribute products manufactured by others may be drawn into liability suits and or corrective measure actions These quasi producers include but are not limited to importers suppliers distributors mail order houses supermarkets and department stores The costs of litigation per defective product will be multiplied because of increasing complexity and multi defendant litigation will also rise Directives and Procedures 23 Product means all movables with the exception of primary agricultural products e g of the soil fisheries and game even though incorporated into an immovable Product includes electricity Producer means the manufacturer of a finished product the producer of any raw material or the manufacturer of a component part and any person who by putting his name trademark or other distinguishing feature on the product pre sents himself as its producer any person who imports a product
145. is the basis for this section Some examples of stability tests are A unit shall not overbalance when tilted to an angle of 10 from its normal upright position the doors and drawers are closed during the test e Floor standing units with a mass of over 25 kg shall not tip over when a force of up to 20 of its weight but not more than 250 N is applied in any direction except upward not exceeding 2 m from the floor e Floor standing units shall not overbalance when an 800 N constant down ward force is applied at the maximum moment to any horizontal working surface or surface for obvious foothold at a height not exceeding 1 m from the floor the doors and drawers are closed during the test Hazardous moving parts shall be so arranged or guarded as to provide ade quate protection against personal injury Protection of the operator is most impor tant and suitable construction methods shall be provided to prevent access to hazardous parts Permitted methods include locating the moving parts in areas that are not operator accessible areas or enclosing the moving parts within an enclosure with mechanical or electrical interlocks that remove the hazard when access is gained Service personnel shall be protected from unintentional contact with hazard ous moving parts and high voltage during servicing of other parts of the equip ment It must not be possible to touch moving parts with the jointed test finger In addition openings p
146. ity is drawn up by the manufacturer or authorized representative and used to declare that the product has undergone all the neces sary assessments and that the product satisfies the essential requirements of the applicable directives This self declaration lists the standards and directives applied the responsible person and other necessary information as required by the directives CE marking is the manufacturer s or supplier s self declaration symbol to indicate that the product has undergone all the necessary evaluation procedures and is in conformity with the minimum requirements of the relevant directives Prod ucts that conform to all the applicable directives and standards may bear the CE marking The CE symbol is not a registered trademark and is in principle under the manufacturer s control Products bearing the CE marking may be placed on the market National authorities enforce European and member state laws at the national level Local authorities have the responsibility for market control through product 6 CE MARKING HANDBOOK checks based on incidents complaints or random audits The authorities take appro priate measures to control nonconforming products including withdrawal fines and possible imprisonment In some states such as Germany the authorities may act with out having to go to court The national authorities are obliged to inform the Commis sion and or the other member states who then also must take the app
147. ive and applies to products and equipment for which the hazards are primarily of an electrical nature and that operate between 50 and 1 000 Vac or 75 and 1 500 Vdc The LVD s essential requirements have been in effect since 1973 and mandate conformity for all safety aspects of electrical products including those of mechanical origin The Electromagnetic Compatibility EMC Directive 89 336 EEC The EMC Directive controls the emissions and immunity characteristics of electrical products and machines called apparatus Electromagnetic compatibility is the ability of an apparatus to operate satisfactorily in its electromagnetic environment EMC is based on the two principles of limiting the electro magnetic energy emissions and affording adequate protection immunity against such energy occurring in the environment The Machinery Directive 89 392 EEC In brief a machine is defined as an assembly of linked parts of at least one that moves and joined together for a specific application for the processing treatment moving or packaging of material The directives essential requirements cover all safety aspects of machinery including mechanical electrical and others The Low Voltage Directive is not needed for machinery since compliance with electrical safety is also required by the Machinery Directive refer to standards EN 60204 1 and others LU Helpful hint If you have trouble determining whether the Low Voltage or Mac
148. iven product or product sector There are seven modules in 93 465 EEC and the generic directives LVD EMC etc or product specific direc tives machinery etc will set the range of choices that may be considered as follows Self declaration This route is available for products machines where a man datory type exam is not required This route allows internal control of pro duction through product assessment and testing by the manufacturer Under self declaration the manufacturer takes complete responsibility for the assessment testing documentation and declaration of conformity and CE marking 30 CE MARKING HANDBOOK Self Declaration Voluntary Certification Mandatory Certification internal control of internal control with EU examination by production by notified or competent EU notified or manufacturer body assessment competent body Manufacturer Performs EU Body Performs EU Body Performs Assessment Assessment Assessment3 Manufacturers Manufacturers Technical File safety Technical File Technical File or TCF EMC with EU Body Report with EU Body Report 4 EU Body Issues EU Body Issues Certificate and Certificate Approval Mark Approval mark available random product checks random product checks Manufacturer Issues Declaration of Conformity Manufacturer Issues Declaration of Conformity Manufacturer Issues Declaration of Conformity and Affixes CE Marking Ship Product to E
149. lecom medical devices etc or voluntary as is the case for most product and machine categories Manufacturers often seek voluntary certifica tion to assure themselves customers and authorities that their products meet the requirements set by law Certification is commonplace in Europe and allows the use of a distinctive approval mark affixed to the product that is backed by a certificate and test report The approval mark is a recognized quality mark attesting to a products conformity to the relevant requirements such as for EMC and safety P Directives tell us why we must comply consumer safety EMC and what may happen if we ignore the laws withdraw products But it s the European standards that show us how to comply design and assessment History The German Model The history of occupational safety in Europe dates back to the turn of the century with safety laws enacted in some countries such as Germany The Acci dent Insurance Act UVV of July 6 1884 was the first of its kind in the world and led to fundamental change Previously compensation for an industrial accident or an occupational disease had to be sought directly from the company itself often Europe s Approach to Total Harmonization 7 a pointless undertaking since it had to be proved that the employer was at fault So a social security system was created from health insurance schemes pension funds and Trade Cooperative Associations BG with the intenti
150. lectrical Safety for Products and Machines This chapter is a step by step approach for equipment safety design and assessment It describes the principles of safety and requirements as found in the European harmonized standards Also included is an easy to follow safety checklist at the end of the section The chapter is a basic design guide for electrical products and machinery that concentrates on component selection and construction tech niques for product safety The information is generally applicable to most product types such as information technology equipment ITE test and measurement devices appliances machinery and other similar equipment The design tips detailed concentrate on problematic areas that manufacturers most often encounter during their first safety assessment This chapter will prove to be an invaluable aid to understanding the safety standards and identifying deficiencies in products Its goal is to give equipment designers and manufacturers a better understanding of Euro pean and international safety considerations including the unique European safety philosophy see also U S and EU Differences in Chapter 5 Understanding this safety philosophy and adhering to a few simple rules will help product manufactur ers to achieve safety conformity on all products manufactured for worldwide export x Guide limitations The appropriate product or machine safety standards take precedence over the guidance and design tips pres
151. lets or inlet filter modules are gen erally easier to deal with for the equipment manufacturer and the installer than fixed cords Tabs are typically provided on the internal side of the inlet for solder or press on connectors Loop the wire through the hole of the tab prior to soldering and tie or sleeve for the second fixing Fixed power cords are common to machinery and household appliances but care must be taken to ensure that the cord strain relief plug and terminal block are type approved and that the proper termination methods and makings are utilized IEC type terminal blocks touch safe are the preferred method for termination of the incoming power wiring Other methods of termination are possible such as for connection directly to circuit breakers mains disconnect switch PCBs and tabs screws on filters Refer to the product standard for the alternative methods of input terminations Solder connections shall not be the only method of fixing and in some cases are not allowed for high current connections Terminal blocks and stranded wire insertion pose special problems because standards require a loose strand test to determine if a single strand can touch any con ductive part upon insertion into a terminal block Using the proper terminal block and or insulation barrier solves this problem Because of solder cold flow problems tinning should not be used to consolidate the wire ends for terminal block insertion Fixed power cords may
152. light colors actuator symbols or warning labels not per standards improper cord plug strain relief user manual missing or not in proper language usually means major deviations internally that could affect safety 1 Ji Market surveillance principle Minor external deviations usually means major internal deviations Example 3 Machine Safety Enforcement in Sweden As an example of machine safety enforcement in 1996 the Swedish govern ment carried out 2 000 workplace inspections The focus was on machines installed after the CE marking deadline The following items were questioned and checked 1 Was a CE marking affixed 2 Was a declaration of conformity in place 3 Were the operator s instructions in Swedish 4 Which notified body was involved for Annex IV machines The results were much worse than expected with 50 of 3 000 inspected machines having one or more deviations and they were only checking paperwork this time The employers received an inspection report and the machine suppliers received official letters describing what must be done to rectify the imperfections In addition 20 000 more compa nies received letters outlining the requirements They were also informed that they could look forward to an inspection in the future The objective of the cam paign was to get the Machinery Directives provisions to be effective in practice The Swedish government is actively lobbying the European Commission and Quality and En
153. ment standards rationale test data safetyfEMC construction and critical components Test reports are an essential tool for conformity assessment of equipment and the key element of a technical file Test reports contain the results of the conformity assessment and need not con tain confidential design information When a EU approval mark is not affixed to the component product or machine in question test reports may be requested by customers testing bodies or enforcement authorities for review and verification purposes In the event that conformity is chal lenged the submission to the enforcement authority of a report drawn up by a notified body i e VDE TUV is considered an element of proof and evidence that the equipment complies with the safety EMC objectives e Certificates and approval marks Visible attestations from European accredited testing and certification bodies that provide positive evidence of conformity Approval marks are product quality marks for safety EMC compliance Certificates and marks are supported by verifiable and accu rate test reports from EU notified or competent bodies Marks and certifi cates establish the independent verification of a product s conformity that customers may demand Regular follow up inspections are performed on equipment with EU approval marks by the certification body to ensure ongoing conformity When issued by recognized European certification bodies official certificates and test
154. mity assessment 27 31 and directives 15 39 Producer liability of 24 Product Liability Directive 21 26 77 and victims rights 22 26 Product specific directives 17 standards 47 48 Production testing 72 114 15 Products approval mark on 58 60 becoming suspect 67 certification 137 41 conformity of 85 defectiveness of 24 defined 3 4 84 89 electrical safety for machines and 83 85 failure of 90 market surveillance of 55 56 passing testing 95 quality 65 67 questionable 77 safety of enforcement in Finland 80 protection and safeguards 18 22 Protection circuit 107 8 thermal 107 8 user 127 Protective earth 120 Q Quality and enforcement 65 82 consultants benefits and limitations 68 69 factory quality 65 67 legal requirements 81 82 market demands 81 82 market surveillance 76 77 product quality 65 67 quality and safety mindset 75 76 U S and EU differences 69 75 R Rating labels 100 Recognition defined 73 mutual 54 Reinforced insulation 86 Reports test 5 32 67 Representative authorized 5 Request duly substantiated 31 Requirements essential 69 harmonized standards and minimum 41 Rights victims 22 26 Risk CE s credibility at 135 36 Rules technical 41 52 S Safeguard clause 21 Safety circuits 117 18 electrical 84 hazards 70 interlocks 87 meaning of 140 of operators 116 principles of 85 87 product 18 22 transformers 118 Safety con
155. mples of primary directives are the Low Voltage Machinery and EMC directives The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products The directives also mandate the publication and mutual recognition of harmonized standards Harmonized standards provide the specific technical rules for product design and conformity testing Standards become harmonized and valid for use once they are published in the Official Journal Harmonized standards known as European Norms ENs give the detailed engineering requirements safety EMC for products such as construction materials wiring components labeling warnings documenta tion and testing and pass fail criteria Conformity to the harmonized standards is recognized as the minimum acceptable criteria However other requirements may also apply Harmonized standards ENs are the cornerstone of the Europe s New Approach and without them the system would not function Presumption of conformity is a phrase associated with products that comply with all aspects of the relevant European harmonized standards National enforce ment authorities are obliged to recognize that equipment manufactured in confor mity with the harmonized standards published in the Official Journal and transposed into national standards are presumed to conform to the essential require ments of the directives When a product is no
156. mum allowable dimensions when measured and with force tests applied Other tests as necessary Depending on the equipment s design and compo nents used numerous other tests may be required by the equipment safety standards The typical electrical safety tests for machinery include but are not limited to see also relevant machine safety standard s Power consumption e Ground continuity e Voltage withstand e Insulation resistance e Capacitor discharge Functional e Safety circuits components and safeguarding Other tests as necessary temperature leakage noise EMC etc The list assumes that all critical and safety components comply with their individual component safety standards and are acceptable for use in the end equip ment Additional tests may be necessary depending on the complexity of the equip ment or components i e specials lasers UV microwave radiation noise and the environment where the equipment will be used residential industrial hazardous locations For test conditions and pass fail criteria and other tests refer to the rele vant product machine safety standard s 18 Production Tests Routine safety tests are tests to which each individual product is subjected during or at the end of the manufacturing process to detect manufacturing variations and unacceptable tolerances in production and materials that could impair safety These tests are performed to check the insulation b
157. n dard numbers or prefixes and are only manufacturer s self declarations 94 CE MARKING HANDBOOK Rating Evidence of Conformity A EU Type Approval 1 Mark Conformity Status 1 and Actions Required 2 Component was tested by European accred ited testing and certification body and bears the Type Approval Mark as positive evi dence on conformity Test report is on file with EU body and available on request End product manufacturer confirms approval by observing Type Approval Mark on component and obtains copy of the approval certificate if necessary for their technical file Pass B Accredited Lab tested 1 Occasionally components are tested by a EU Accredited Lab DAR for Germany and do not bear a type approval mark The lab accreditation certificate test report and test verification must be readily available The lab accreditation certificate and test verification is obtained by end product manufacturer and placed into the technical file It is also advisable to obtain a copy of the test report for review Conditional acceptance case by case C Manufacturer 1 Self Test CE marking Component supplier claims to meet EU safety standards i e EN IEC VDE and offers CE marking in lieu of type approval mark Since self declarations and CE are not positive evidence the end product manu facturer should
158. nce consumers or users modules A Aa B C and Not for components since components have no autonomous use except in a few cases see Components in Design Guidance in Chapter 6 FIGURE 2 8 General Guidelines for Affixing and Use of the CE Marking A 3 Q 4 A 4 Q 5 A 5 Directives and Procedures Yes According to Council Decision 93 465 EEC of 22 July 1993 concerning the rules for affixing the CE conformity marking a product may bear different marks Other product marks are only prohibited if they are liable to deceive third parties as to the meaning and form of the CE marking or if they are liable to cause confusion with the CE marking Quality markings as opposed to the CE marking are voluntary address consumers or users and tend to influence their appreciation toward the relevant product Thus they have a different function to that of the CE marking They are therefore acceptable Is the Commission aware that such national seals of approval are held in higher esteem Yes The CE marking is not a quality marking although it is often wrongly perceived as such and then compared to other quality marks The Commission tries to remedy this situation by inform ing industry as well as the authorities responsible for market sur veillance about the correct meaning and function of the marking Furthermore the second version of the guide to the implementa tion of Community harmonization Directives bas
159. nd 2 are sold to the end user but not when sold to manufacturer s or assemblers Some components may bear CE marking under the EMC directive Examples of components include personal computer circuit cards computer disk drives PLCs stand alone power supplies electric motors except induction and electronic temperature controls Because of the competitive nature of the marketplace component suppliers often place CE on components for sales and marketing purposes even when a direc tive does not specifically allow it There are a few provisions for CE marking of components under the Low Voltage and EMC directives that some manufacturers and suppliers take advantage of to satisfy customers demands albeit oftentimes misinformed by affixing an unqualified CE marking Manufacturers CE markings and self declarations for components without EU type approval marks may make the claim of conformity difficult to prove Most components do not need CE mark ing and where it exists CE is not evidence of compliance from a European recog nized third party 6 Warning The Commission has disallowed CE marking of com ponents when their safety to a very large extent depends on how they are integrated into the final product Some suppliers still persist in marking components with an unqualified CE A major problem with products and machines submitted to EU testing bodies is that they fail assessment because the components do not con
160. nd are only self declarations and are not evidence of compliance from an independent European body Low Voltage Directive LVD of 1973 is the primary directive for safety com pliance of electrical equipment The Low Voltage Directive was a real groundbreaker in European standardization and certification because of the numerous EN and IEC standards published setting the technical rules for equipment and components The LVD covers safety of all electrical products that operate at 50 to 1 000 Vac or 75 to 1 500 Vdc Products covered by the LVD include Information Technology Equip ment EN 60950 Test and Measurement Devices for Lab Use EN 61010 1 Elec tronic Apparatus for Household Use EN 60065 Household and Similar Appliances EN 60335 and others The appliance standards also cover similar products that are for residential or commercial use such as deep fat fryers cooking ranges electric pumps and generators clothes dryers and washers floor cleaning equipment and many others See Equipment Classification for more examples Electrical safety is not limited only to products covered by the Low Voltage Directive LVD According to the Machinery Directive machine designers must also be aware of electrical safety since machines pose electrical hazards and they utilize numerous electrical components and subassemblies The Low Voltage Directive General Product Safety Directive and Machinery Directive mandate a product s con formity
161. nd speedier in the event of challenge by authorities refer to Notified Bodies and Due Diligence sections in Chapter 4 For safety assessments the testing performed may actually be minimal depending on the equipment in question and the standard s applied The safety assessment usually involves considerable time verifying a product s conformity with the construction and components requirements according to all the clauses of the applicable standards see Design Guidance in Chapter 6 For EMC the majority of the assessment and time spent involves the tests themselves The resulting EMC report s contain for the most part test data and test configuration with some con struction and components information If the test report is not available the cus tomer and or certification body has the right to doubt conformity of the component product or machine under consideration L Test reports may be requested by customers certification bodies or enforcement authorities for review and verification purposes The EMC Directive sometimes mandates the use of a competent body for mandatory certification and a special file called the technical construction file TCF This is the case when no harmonized standards exist or they are applied only Directives and Procedures 33 in part The TCF is generated by the manufacturer in conjunction with the compe tent body This process is commonly called the TCF route and is a certification process th
162. nd interpretations is the mini mum acceptable criteria The U S and EU standards deal with environmental dust and water requirements for industrial areas from different perspectives In the European standards ingress protection IP via dust and water tests is mandatory for most machinery and some products The dust tests are especially important for shock protection since dust found in industrial environments often contains metallic parti cles Dust with even small amounts of metal particles can cause shock hazards This can occur when dust is deposited over high voltage circuits within the equip ment that eventually cause high voltage to arc over to touchable secondary circuits or the enclosure presenting a danger to operators When EU standards require ingress protection i e IP54 i e for machines both dust and water tests are per formed see Design Guide Enclosures in Chapter 6 In the United States there is a tendency to focus on water testing NEMA alone or in place of dust testing Even water testing may not be required in the United States unless the equipment is intended for outside use or use in extreme industrial environments Performing a water test in place of the dust test is not unheard of in the United States but is not permitted in the EU standards BA Substitution testing may not take the place of the required tests Frequently equipment passes water testing but fails the dust test Another area where U
163. nd maintenance of the machine shall be supplied The information must be provided by the machine supplier to the buyer before deliv ery of the equipment Circuit documentation diagrams tables descriptions serve to explain the function of circuits power connections and process oriented func tions see IEC 204 2 617 1 848 1082 Documentation shall include 1 Description of machine installation and mounting and the connection to the electrical supply 2 Electrical supply requirements 3 Physical environmental information i e lighting vibration noise levels atmospheric contaminants where appropriate 4 Circuit diagram s System or block diagram s where appropriate 6 Information where appropriate on programming sequence of operation and inspection frequency and method of functional testing guidance on adjustments and maintenance especially on the protective devices and cir cuits parts list in particular the spare parts 7 Description of the safeguards interacting functions and interlocking of guards for hazardous movements and 8 Description of safeguarding means and methods where the safeguards are suspended n Refer to the appropriate standards for the documentation requirements This section is an introduction to key machinery requirements according to EN 60204 1 and other related standards Other require ments and standards may apply including but not limited to risk assessment safety c
164. nd the other two don t As a manufacturer or user of components products or machines do not allow yourself to fall into the trap of unCErtainty Consumers and inspectors have the right to demand positive evidence of conformity from independent accredited parties CE markings and declarations alone are not adequate to verify the safety or EMC con formity of components or equipment L Always obtain positive evidence of conformity EU approval marks certificates test reports Play it safe and you won t get burned Self Test Where Are You Now You may be surprised and even discouraged at what first appears to be the work involved to achieve European Conformity for your products At this point you can either fight it and continue to ask Why me or simply apply the rules and accept them Remember for the most part the world is or soon will follow the European safety EMC quality and environmental rules It is sometimes difficult for us to change our ways of thinking but once we learn and apply the principles to the design and manufacturing of the first product achieving subsequent product confor mity will be much easier if not automatic Conclusion 137 Now that you have a greater appreciation of product assessment and testing for the CE marking take a self test just for fun Figure 7 1 You may check any box below but the sooner you attain acceptance the sooner you can ship products to the European Union
165. ndards and interpretations are generally con sidered to be more strict see U S and EU Differences in Chapter 5 Without mutually agreed upon standards it would be difficult to establish conformity in quantifiable engineering terms to determine whether a product or machine meets any minimum safety levels or technical requirements When harmo nized standards are not used a presumption of conformity does not exist This places the manufacturer in a potentially indefensible position should their equip ment become suspect by customers competitors or enforcement authorities Some manufacturers looking for loopholes refuse to apply the harmonized standards or only apply them in part pick and choose saying they have shipped numerous products to Europe and they have not injured anyone Be wary of this rationale as it does not establish conformity but instead should alert the buyer to potentially non conforming products A product s verifiable conformity to the harmonized stan dards goes a long way to satisfy your customer s compliance concerns and is a good defense if your equipment s conformity is questioned by authorities This Page Intentionally Left Blank CHAPTER 2 Directives and Procedures The only thing more expensive than education is ignorance BENJAMIN FRANKLIN Directives The European Laws European directives are laws that manufacturers must meet before affixing the CE marking to products The directiv
166. ned in the documentation i e user instructions or alter natively such information shall be marked on the equipment Some of the more common warning symbols are CAUTION Risk of electric shock CAUTION Hot surface CAUTION General warning refer to accompanying documents gt p Note Except for General waming signal words and text are not required when symbols are present signal words are CAUTION DANGER WARNING Depending on the applicable product standard colors are typically black symbols and outlines triangle on a yellow background The symbol shall be placed as close as possible to the hazard to warn the operator and or service person before the haz ard is accessed 16 Flammability of Materials Flammability requirements are intended to minimize the risk of ignition and the spread of flame both within the product and to the outside A fire enclosure is defined as a part of the product intended to minimize the spread of fire or flames 1 Symbols courtesy of Hazard Communication Systems Inc HCS Milford PA 112 CE MARKING HANDBOOK within A decorative part is a part outside the enclosure that has no safety func tion Fire enclosures and components and parts inside an enclosure must be so constructed and make use of materials as to minimize the propagation of fire Some materials and components are exempt from the requirements such as small components cable ties and small parts mounted on PCBs
167. nformation required for safety functions and markings for the product in question with reference to other standards for details Figures 6 8 and 6 9 show push button and indicator light colors and their meanings Markings for machinery are the best defined and various standards detail the accepted conventions e g EN 60073 and EN 60204 1 for colors and mean ings IEC 1310 1 2 and ISO 7000 for actuator movements hazard symbol types and sizes L Item Designations tem designation markings are required within the equipment for machine parts and terminals to ensure ease of identification and maintenance These markings help service personnel to correlate the parts in the equipment to the different diagrams parts lists circuit descriptions and instruc tions All items such as basic parts components terminals subassemblies and 124 CE MARKING HANDBOOK Examples and application Color Meaning Explanation Red Emergency Actuate in case of haz Emergency conditions ardous condition or Initiation of emergency function emergency Used for E Stop actuators Yellow Abnormal Actuate in case of Intervention to suppress abnormal abnormal condition condition Intervention to restart an interrupted automatic cycle Green Safe Actuate in case of safe Reserved for functions indicating a safe or normal condition situation or to pre pare normal Actuate in case of con Reset function dition r
168. ng One of the goals of the Global Approach is to harmonize conformity assessment to create the conditions essential for engendering confidence and hence the establishment of mutual recognition Consequently prior to affixing the CE marking to products manufacturers must either conduct conformity assess ment on their products by themselves if they are competent and properly equipped or subject their products to conformity assessment by specialist third parties These spe cialist third parties consist of European testing laboratories and certification bodies commonly known as notified competent bodies safety EMC 1985 The New Approach Harmonized directives essential requirements e Harmonized standards technical rules 1989 The Global Approach e Conformity assessment procedures the modules CE marking rules manufacturer s self declaration Products must conform with the Essential Requirements ERs of all relevant directives before being placed on the market ERs are at the center of European law and standards and are retained for the presumption of conformity by virtue of their publication in the directives as harmonized standards The ERs and harmo nized standards include the requirements to protect consumers health merchan dise and the environment The transposition of the European directives and harmonized standards into national laws and standards makes them legally binding and obligatory in the member states Products
169. ng data shall be filed e Date of test e Model number Serial number or another identifier permitting unambiguous identification e Value of voltage applied during the electric strength test Value of the earthing circuit resistance and corresponding current value e Reference information that complete set of tests has has not been successful Depending on the equipment s design additional tests may be required Besides the applicable equipment safety standards special Routine Test Standards exist such as EN 50116 for Information Technology Equipment ITE EN 50106 for Household Appliances EN 50144 1 for Handheld Motor Operated Tools ENEC 303 for Luminaires and CCA 201 for Certified products 19 Additional Requirements for Machinery This section addresses additional requirements according to EN 60204 1 IEC 204 1 for the electrical safety of industrial machines The requirements presented in the previous sections are applicable to machines and are for the most part contained in EN 60204 1 or other associated standards I will point out some of the key electri cal safety items that are often overlooked by the beginning machine safety inspector EN 60204 1 does not cover all machine safety requirements for guarding interlocks control and so on that are also applicable and listed in the Machinery Directive Notice To ensure the machine s conformity with all the electrical safety requirements a complete assessment according
170. ng water when than 12mm tilted up to 15 Protected against Hii Protected against solid objects greater spraying water than 2 5mm Protected against solid objects greater than 1 0mm Protected against splashing water Dust protected Protected against water jets Dust tight Protected against heavy seas Protected against the effects of immersion Protected against submersion Notes EN 60529 outlines an international classification for the sealing effectiveness of enclosures of elec trical equipment against the intrusion into the equipment of foreign bodies i e dust tools fingers and moisture This classification system utilizes the letters IP Ingress Protection followed by two digits An X is used for one of the digits if there is only one class of protection i e IP X4 which addresses moisture resistance only EN 60529 does not specify sealing effectiveness against the following the risk of explosions cer tain types of moisture conditions e g those that are produced by condensation corrosive vapors fungus vermin FIGURE 6 6 Ingress Protection IP Levels per EN 60529 IEC 529 Courtesy of Panel Components Corp Oskaloosa IA Design Guide for Safety Conformity 123 Ground Electrical Enclosure IP54 FIGURE 6 7 Electrical Enclosure IP54 Courtesy of Rittal Corporation Springfield Ohio will cover specific i
171. nother objective of the IEC is to provide a common reference for international trade through standards This goal of one set of universally recognized standards is fast becoming a reality for worldwide prod uct acceptance The concept of European Conformity CE marking revolves around Euro pean harmonized standards as the minimum requirements for product design and assessment Strict adherence to these technical specifications should be the focus of all designers and manufacturers Manufacturers can and should do more than the standards require and certainly should not do less In reference to the confor mity assessment modules the CE Marking Directive 93 68 EEC OJEC L220 21 states the choice of procedures must not lead to a lowering of safety standards of electrical equipment which have already been established throughout the Community 41 42 CE MARKING HANDBOOK The European Commission mandates the creation of standards to support the essential requirements ERs of the directives A standard is considered har monized at the time of announcement which is published in the Official Journal of the European Communities OJEC Compliance with the harmonized standards will in most cases ensure a product s conformity with the essential requirements of the directives Adherence to European harmonized standards is the only proven and universally accepted method of showing conformity with the ERs of the directives Figure 3 1 Properl
172. nt as long as the declara tion contains the necessary elements laid down in the appropriate directives The declaration should be drawn up in the same language as the original instructions of use and must be typewritten or handwritten in block capitals The following declara tions Figure 2 7 are for illustration only and not a recommendation Standards and requirements may be changed or added at any time CE Marking Guidelines According to the Official Journal A single CE marking should be used in order to facilitate controls on the Community market by inspectors and clarify the obligations of eco nomic operators manufacturer or supplier the aim of the CE mark ing is to symbolize the conformity of a product and to indicate that the economic operator has undergone all the evaluation procedures laid down by Community law in respect of his product OJEC 93 465 EEC It is well advised that manufacturers and suppliers be informed not only of the CE marking s advantages but also of its limitations The CE marking is not a mark or certification or approval The CE marking is not for sales or marketing or promotion 34 CE MARKING HANDBOOK Declaration of Conformity ABC GmbH Street City Postal Code Germany Type of Equipment Model Name Model Type Number Year of Manufacture Application of Council Directives Standards to Which Conformity Is Declared Safety EMC Manufacturer s Name Manufactu
173. nt glass nameplates mounting feet keycaps knobs lacing tape twine cable ties ceramic materials metals others Manufacturers should select components and materials that have been previ ously flammability tested Because of the popularity and focus on flammability in the United States hot flaming oil test and fire enclosures many materials and components have been tested and rated by UL European testing and certification bodies generally recognize the UL flammability test results and classifications 17 Electrical Safety Testing Once the product meets all of the applicable design component and construc tion requirements detailed in the previous sections and the relevant safety standards the electrical safety testing begins For machinery the subsequent sections and the relevant machine safety standards should also be met prior to testing Design Guide for Safety Conformity 113 LU This section is only a brief overview of electrical safety tests Refer to the standards for performing the tests and the pass fail criteria Type tests are performed on a representative test sample or prototype of the equipment in question The terms type and model are interchangeable When a prod uct complies with the component and construction requirements and successful test results are achieved then all models of a given type are assumed to comply e g of the same design and identification number model number The equipment sh
174. nt subject to official registration in Norway the party responsible for the marketing shall be registered by the Norwegian Directorate for Product and Electrical Safety Morten Smith Nemko AS P O Box 73 Blindern N 0314 Oslo Norway Telephone Fax 47 2296 03 30 47 229605 50 Enterprise number NO 974404532 FIGURE 4 4 Component Safety Certificate Notified Bodies and Certification 63 Licence No VDE Priif und Zertifizierungsinstitut Reve Zeichengenehmigung 000000 F ae und Siz des Zeichengenehmigungs inhabers Name and registered seat of the marks scence Podar Company XYZ Fectiqungsstatie Plece of manufacture AA Factory ABC Statistik Statistics Aktenzeichen File Datum Date 1 12345 3251 0001 12345 TF1 Datum VDE EMV Zeichen VDE EMC Mark DE EMV Die Bedingungen zum Benutzen des Zeichens sind aut Blatt 1 von lt Datum gt genamnt Tha conditions to use the mark are referrad to on page 1 of lt date gt dahresgebithren Einheltery annual fee units Auf Grund der Pr fung nach den unten angegebenen harmaonisierten europ ischen Normen in Verbindung mit dem Artikel 10 1 der EG Richtlinie 89 336 EWG vom 03 Mai 1989 umgesetzt in das EMV Gesetz vom 09 November 1992 Gesetz Uber die elektromagnetische Vertraglichkelt EMVG antsprechen die in diesem Ausweis aufgef hrten Ger te den grundlegenden Schutzanforderungen zur elektromagnetischen Vertr glichkeit EMV Based on the test a
175. nts i e gt 50 Vac 60 Vdc or in safety circuit do not bear a Type Approval Mark from a EU recognized body then the designer must confirm that it meets the relevant EN IEC standards or perform a complete evaluation and testing of the component according to the relevant component standards Remember A CE marking on a component is not an EU third party mark additional testing may be necessary see Components in Chapter 6 In general only one standard is needed but in some cases several standards are required such as for electrical mechanical documentation and others Also do not forget the ERs of the relevant directives and the market expectations refer to Essential Requirements in this chapter and Product Liability in Chapter 2 L All hazards and relevant standards must be addressed this means that no hazard or component is to go unchecked even if the main product standard does not address a particular hazard risk component etc The standards and other regulations address all possible hazards concerning the protection of consumers animals property and the environment The operator of the product machine is generally the focus of protection but the standards may require protection of service personnel see Design Guidance in Chapter 6 Possible hazards are e Electrical e Energy e Mechanical e Temperature Fire e Chemical e Gases Radiation e Pressure Others Standards like directives come in three
176. nts such as fail safe design posi tive opening and nonoverridable type Double fixing is a method of ensuring adequate retention of wire terminations and protecting the user should a single fault occur According to the single fault con cept two levels of protection must be provided for operators to prevent electric shock caused by a fault such as a wire breaking fastener or connector coming loose and other malfunctions Various methods of double fixing should be provided as pro tective measures such as liberal use of wire ties double crimp terminations and sleeving so that a single fault and its resulting faults will not create a hazard Other hazards such as fire mechanical heat radiation and chemical reac tion must also be prevented to protect the operator and service personnel even if the main product standard does not specifically refer to those hazards Refer to the appropriate standards for requirements on the limiting guarding and warnings for these hazards Instructions warnings and symbols may be required to alert users and service personnel to possible hazards The type size color and symbols are specified in the standards and sometimes mentioned in a directive machinery For electrical prod ucts the standards dictate the necessary warnings and where they must be provided product and or manual The standards state that any required safety instructions and markings be in the language of the country where the product
177. o ask the customs authorities to include the fol lowing endorsement on the commercial invoice accompanying the product and any other relevant document Product not in conformity trelease for free circulation not authorized Regulation EEC No 339 93 To implement this regulation Directive 81 1468 EEC was published on mutual assistance between the administrative authorities of the member states and cooperation between the latter and the Commission to ensure the correct application of the law on customs matters Note This section focuses on key elements of the directive and is only a part Refer to the directives for the complete text The actual wording of the directives is binding Conformity Assessment Procedures The Modules Directive 93 465 EEC concerns the various phases of the conformity assess ment procedures known as the modules and the rules for affixing the CE confor mity marking which are to be used in conjunction with the technical harmonization directives This section focuses on the modules for the LVD EMC and Machinery directives and gives an introduction to the CE marking This directive introduces a common doctrine of conformity assessment and methodology to facilitate the plac ing on the market of products The methods should ensure full conformity with the Essential Requirements of the directives in particular for the health and safety of users and consumers In addition the directive clarif
178. o satisfy society s global needs Besides satisfying the needs of the enforcement authorities of paramount importance are the needs and protec tion of the user The DIN informs the state authorities of any standardization work and completed standards In the past the standards were typically released as DIN or DIN VDE standards but now DIN checks how the newer DIN EN standards and the EU directives translate into German law and use by the authorities In fact the German safety and RFI EMC laws as well as the standards have served as models for the New Approach and are now adopted at the European Union level The German RFI law HfrG of 1949 required conformity to various RFI legisla tion and standards for compliance European and international working groups modified these German RFI laws and released them as European EMC laws and standards CISPR The same process occurred for safety with the German Equip ment Safety Law GSG being the model for Europe s Low Voltage and Machin ery Directives As an example of standards history and progression the German ITE safety standard DIN VDE 0805 became EN 60950 IEC 950 machine safety standard DIN VDE 0113 1 became EN 60204 1 IEC 204 1 machine EMC standard DIN VDE 0875 became EN 55011 CISPR 11 and appliance EMC standard DIN VDE 0875 1 became EN 55014 CISPR 14 Except for EMC immunity the majority of European product safety machinery and EMC standards are traceable back to their Ge
179. objec tives Article 2 and Annex 1 The manufacturer or his authorized representative established in the Community may wish in certain cases to ask in advance for a report to be drawn up by a notified body in accordance with the procedure pro vided for in Article 11 and keep it together with the technical documen tation The availability of such a report would make matters easier and speedier in the event of challenge by the authorities When customers see an approval mark they know and trust i e VDE TUV BG they can be assured that the testing was performed to exacting quality stan dards and that an accurate test report and certificate exist Figure 4 2 shows the hierarchy of European conformity acceptance With today s liberalized approach CE self test where testing and approvals for most products are no longer com pulsory the quality of the approval mark is more important than ever There is a greater potential for abuse under the new system that must be counteracted by effective surveillance checks by the authorities users and competitors Product manufacturers and suppliers should utilize testing and approval bodies with the Notified Bodies and Certification 59 Description Advantages Disad vantages Approval Marks The highest level for conformity verification and acceptance in Europe are the voluntary prod uct safety and EMC Approval Advantages Approval Mark
180. odel relationship 113 tests 113 U U S United States and EU differences 69 75 focus on flammability and testing 12 safety testing 74 User protection 127 Vv Verification conformity 93 95 Victims rights 22 26 Vision tunnel 46 47 Voluntary certification 31 57 W Warning symbols 127 Warnings 87 110 11 Wire colors 104 5 Wiring 119 20 separation of internal 105 6 terminals 104
181. oduct is in conformity with the requirements of the Low Voltage Direc tive 73 23 EEC and the EMC Directive 89 336 EEC European Contact John Doe Quality Manager ABC Co Bonn Germany Fax 49 XXXX XXXXXX Signature name title location date FIGURE 2 7b Sample Declaration Laser Printer The term CE mark was changed to CE Marking in the New Approach Direc tives The CE marking is not a mark and therefore must not be confused with a mark certificate or approval issued by an accredited certification body as listed in the Official Journal Rather the CE marking is a symbol of the manufacturer s declaration of conformity that implies conformity with the minimum requirements set out in the Directives The CE symbol is not a registered mark which is in princi ple under the manufacturer s own responsibility The CE marking is a declaration for the inspectors i e customs and allows the product to be placed on the market 36 CE MARKING HANDBOOK Declaration of Conformity Manufacturer ABC Co Factory 1234 Street San Francisco CA USA ABC Co 1234 Street San Francisco CA USA Name of representative XYZ Co Address EU COUNTRY Machinery description Semiconductor Pick and Place Machine Model Type number IC KXX YY I hereby declare that the machinery complies with the Essential Health and Safety Require ments of the Machinery Directive 89 392 EEC and with the provisions of
182. on 105 6 basic 86 five types of 105 reinforced 86 safer than fusing 98 supplementary 86 Interlocks safety 87 IP ingress protection 72 121 Isolating transformers 118 ITE information technology equipment 16 83 108 115 Items defined 124 designations 123 27 L Labels rating 100 Languages 110 11 Laws European 15 18 safety EMC 7 Legal requirements 81 82 Liability 68 and component safety 89 92 of producers 24 strict 22 77 Listing defined 73 LYD Low Voltage Directive 8 16 17 46 84 85 89 90 applications of 85 M Machine safety enforcement in Sweden 80 81 Machinery Directive 11 17 115 failure of 90 miscellaneous requirements for 1 15 33 E stop emergency stop switches 117 enclosures 121 fault tolerant components 117 18 functional markings 121 23 item designations 123 27 mains disconnect switches 116 17 Index 151 manuals 127 28 motors 118 19 operator access areas 120 PE protective earth 120 protective measures 116 safety circuits 117 18 technical documentation 128 33 transformers 118 warning symbols 127 wiring 119 20 Machines electrical safety for products and 83 85 Mains disconnect switches 116 17 Mandatory certification 30 31 Manuals 127 28 Manufacturer defined 4 5 Market demands 81 82 surveillance 76 77 of products 55 56 Marketing and CE marking 66 Markings 100 101 functional 121 23 Marks approval 56 57 67 third part
183. on the product supplier Strict liability means that in the case of a claim the producers of a defective product can no longer exonerate themselves by proving no fault Even a defense of due diligence may no longer protect the producer from liability The due diligence defense is still to have some importance although it may be more diffi cult to prove Since the negligence no fault defense no longer exists the notions of defectiveness state of the art and consumer expectations are of new importance Quality control documentation and warnings also gain increased significance With respect to safety EMC conformity producers must document their quality control pro cedures and have a duty to warn consumers of hazards C7 Since the Product Liability Directive was implemented a trend toward American style liability has resulted and civil lawsuits are on the rise in Europe Strict liability applies to producers or suppliers of any end product raw material or component as well as to the quasi producers those who present them selves as producers by affixing their name trademark and other distinguishing fea ture on the product Losses in the area of consumer goods are more likely producers of industrial products i e machines will encounter more actions resulting under worker liability claims and compensation Component producers may also face claims caused by the defective product components of th
184. on to give manual and white collar workers material support in the event of sickness old age or accident at work A special feature of the German accident insurance system is that compensation for an industrial accident or occupational disease can be claimed from the BG who assumes liability in place of the individual companies Some of the Accident Prevention Regulations VBG and safety codes and guide lines ZH issued by the BG apply to all branches of industry Others address par ticular machines facilities or sectors of industry such as office workplaces The Accident Prevention Regulations also serve the implementation of national laws having the status as statutory ordinances In addition to accident insurance and safety regulations the BG is a enforcement body in charge of monitoring company compliance with accident prevention regulations and workplace protection stan dards The BG inspectors advise manufacturers on the safety and ergonomic design of tools and machines and they are involved in safety checks on products and equipment As is commonly known Germany has strict safety EMC laws and enforce ment Through the German Ministry of Labor safety EMC laws are passed by vol untary consensus with the support of the general populace consumer protection groups and the BG These laws pave the way for the legality and recognition of standards Historically the Deutsches Institute for Normen DIN has worked to establish standards t
185. or consumer rights advocate you might have assumed that products on the European market place displaying the CE symbol guaranteed that the product had undergone strin gent safety and electromagnetic compatibility EMC testing to have the right to bear this coveted mark First of all the term CE mark is incorrect It was amended in the directives to CE marking which differentiates the suppliers self declaration CE from a approval mark VDE TUV issued by an accredited European Union EU certifica tion body Furthermore it is not accurate to refer to CE as a self certification as it is really only a self declaration and no more Therefore it will always be referred to it as CE marking as used in the directives themselves It is a symbol of the supplier s self declaration and not a certification approval or mark of any kind BA There is no such thing as a CE approval or CE certification CE is not a mark or approval it is a marking which is only a self declaration under the suppliers own responsibility CE Marking Handbook A Practical Approach to Global Safety Certification strives to clear up the confusion surrounding CE marking With CE marking now mandatory for most equipment products appliances machines etc bound for Europe it is paramount that you the manufacturer or exporter gain a thorough understanding of the New Approach now in effect after the transition period from the Old Approach has ended to better ensur
186. ore basic parts that form a portion of an assembly replaceable as a whole but having a part or parts that are individually replaceable such as overcurrent protective device filter unit terminal board An assembly is a number of basic parts or subassemblies or any combination thereof joined together to perform a specific function such as electrical generator audio amplifier power supply or switchgear assembly Items are defined as a basic part component equipment or functional unit and are usually denoted by graphical symbols on diagrams Resistors relays generators amplifiers Design Guide for Safety Conformity 125 Explanation Action by operator Examples of application Emergency Hazardous condition Immediate action to Pressure temperature out of deal with hazard safe limits ous condition e g Voltage drop by operating E Stop Breakdown device Overtravel of a stop position Yellow Green White Neutral Abnormal Abnormal condition Impending critical condition Monitoring and or intervention e g by reestablishing the intended function Pressure temperature exceed ing normal limits Tripping of protective device athe Normal Normal condition Optional Pressure temperature within normal limits Authorization to proceed Indication of condi tion which requires action by the operator Mandatory Mandatory action Instruction to enter pre
187. orities and removes the need for consumers to prove negligence in a legal action The consumer may take action against all parties involved in the supply chain simultaneously joint and several The manufacturer s best defense is likely to be that they took all available steps to ensure conformity due diligence Directive 85 374 EEC concerning Liability for Defective Products Product Liability Directive was enacted in 1987 to protect consumers from defective 24 CE MARKING HANDBOOK products This directive states that all producers involved in the production pro cess shall be made liable insofar as the finished product component or raw material supplied by them was defective and that the liability should extend to importers and persons who present themselves as producers by affixing their name to the product To protect the physical well being and property of the consumer the defective nature of the product should be determined by reference not to its fit ness for use but to the lack of safety that the public at large is entitled to expect This Directive therefore puts responsibility on the supplier to produce safe prod ucts through the pressure which the costs liability places on him after an accident due to a defective product OJEC 89 C 267 03 L A product is considered defective when it does not provide the safety that a person is entitled to expect The directive does not set financial ceilings on a prod
188. orted will be to reduce undue strain on the terminations of the conductors Internal wiring should be identified by the proper colors and numbers and identification tags shall be legible and permanent The conductors shall be iden tifiable at each termination and in accordance with the technical documentation The minimum cross section of single or multicore wires is 0 75 mm and flame retardant wire insulation should be used e g V 2 min The color coding is listed in EN 60204 1 and IEC 757 with the following colors specified Neutral Light blue Safety and protective earth PE Green and yellow AC or DC power circuits Black AC control circuits Red DC control circuits Blue Interlock circuits external source Orange Note Green or yellow should not be used since there is a possibility of confu sion with bicolor green and yellow PE 120 CE MARKING HANDBOOK All live power conductors except the earthed neutral shall employ overcurrent protection selected as low as possible but adequate for the anticipated start up cur rents Control circuits conductors connected directly to supply voltages and circuits feeding control circuit transformers shall be protected Refer to EN 60204 1 for more information H Protective Earth The protective earth PE terminal for the external ground earth conductor shall be marked with the letters PE The PE designation is restricted to the terminal for bonding of the external protective conductor gr
189. other Mains circuit protection Fuse circuit breaker type T F etc ___ Size __A ____Vac DC Thermal protectors motors trans formers type ___ size other info Fuse therm protector approvals and locations VDE S or other location s Stability and mechanical require ments impact tests drop tests hand held products stability of nonfixed equipment enclosure openings access hazard guarding refer to standards for requirements and tests Al 132 CE MARKING HANDBOOK Directive s Standard s IEC symbols black yellow leak age laser dual fusing high voltage energy moving parts high temp other s Instructions text in manual s and warning sym bols on equipment Language s English French German other s as required Plastics flammability Enclosure wire insulation decora tive parts other parts Tested by ___ cert s on file Electrical safety tests Power consumption see 5 Ground continuity Voltage withstand Insulation resistance Earth leakage Capacitor discharge Temperature rise Stability and impact see 14 Creepage and clearance see 10 Abnormal and fault conditions see 8 Others Test data attached Production tests Hi pot 1 500Vac 2 120Vdc for 1 sec Ground Continuity 25A or 1 5 max inp Other The Safety Checklist Company Factory Eng Date Design Guide
190. ould be tested at normal operating conditions and carried out under the most unfavorable combination of the manufacturer s parameters for supply voltage frequency and so on and under full load per standards i e 10 rated voltage The number of tests will vary from only a few tests such as for equipment that uses all EU type approved critical and safety components to numerous testing for complex equipment using custom or nonapproved components and subassemblies Using nonapproved components where conformity is not verified may require con siderably more testing on the end product manufacturer s part Some of the more common electrical safety tests for products include but are not limited to Power consumption Establishes the total power current consumed by the product for input rating circuit protection and testing Ground continuity Tests the ability of the grounding system to withstand a high current i e lt 25 A for 10 sec between touchable metal covers enclo sures doors and the mains ground PE Voltage withstand The ability of a product s insulation to withstand high voltage between circuits i e 3 000 Vac prim to sec for 1 min This test is sometimes referred to as hi pot or electric strength test e Insulation resistance The system s insulation resistance between power circuits and the protective earth circuit 500 Vdc applied Earth leakage Measures any current that leaks onto the e
191. oundings or damage to the machine The E stop shall stop the dangerous elements of the equip ment or stop the entire machine as quickly as practicable The purpose of the E stop is to stop the machine in case of danger and disconnect it from the supply voltages When operating all loads that may lead to a hazard to personnel or damage to the machine must be disconnected by deenergization so as to deenergize contactors relays or the undervoltage release of the main disconnect switch eo Emergency stop devices are required for machinery They shall have a red button on yellow background be self latching positively opening readily accessible to operator manually activated require manual reset Resetting the E stop switch shall not restart any part of the machine There are several possible E stops The palm or mushroom head type is the most popular The actuator must be readily visible and easily reached by the opera tor from the working and operating positions Several E stop devices may be required to cover all the machines working or operating positions The mushroom head or other actuator must be red and the background yellow to clearly identify the device as an emergency stop switch A combined supply disconnect E stop device also exists and must meet all the E stop and color requirements The requirements for E stops are defined in various standards such as EN 60204 1 and EN 418 D Fault Tolerant Components and Safety Circuit
192. ow and recognize VDE TUV is often a marketing requirement because of the consum ers greater awareness of standards Voluntary certification is actively encouraged by the government manufacturers insurers and consumer groups They expect high quality and safe products and look for third party approvals on the products they buy Technical requirements and safety EMC laws and standards exist to protect the consumer from dangerous occurrences caused by products The German Equipment This section is based in part with quotations or facsimiles contained herein on the DTI Depart ment of Trade and Industry UK brochure Exporters Guide to Technical Requirements in the Fed eral Republic of Germany 76 CE MARKING HANDBOOK Safety Law GSG of 1968 says that all products must be safe and meet the rec ognized rules of technology A product s conformity with the relevant standards is deemed to satisfy the law presumption of conformity German national laws such as the Accident Insurance Act are in place to encourage product manufacturers to supply safe products and enforce conformity through the users and local authori ties The Accident Insurance Act requires accident coverage to be taken by employ ers from labor organizations known as the BG that cover workers for industrial injuries It is a legal requirement that both the employer and employee comply with the Accident Prevention Regulations The German s
193. per classification such as a V 2 flame rating for insulation on internal wiring or lt HAR gt marked for external fixed power cords English or metric sized wires are acceptable Internal wires are held in place independently of the connection to meet the single fault requirement by wire ties or similar methods Make the second fixing as close to the initial connection point as possible so that if the wire breaks or comes loose it will not make contact with metal or live parts It is assumed that two inde pendent fixings will not come loose Using the proper IEC type terminals as instructed by the terminal manufac turer will reduce any termination problems Wires are not considered reliably secured to terminals unless there is either an additional fixing provided near the ter minal or the terminal has terminators i e ring lugs For press on or similar termi nators a double crimp is preferred e g one crimp on the wire and one on the insulation Because of the many plug and socket types in Europe designers often prefer inlets for use with detachable cord sets instead of fixed cords and plugs The cord set 104 CE MARKING HANDBOOK does not need to be listed on the CDF EN 60320 type inlets are available for up to 15 A input and EN 60309 pin and sleeve types are available through 150 A or higher The U S NEMA twist lock style inlet does not meet the IEC standards and therefore is not allowed for use in operator accessible areas In
194. propriate harmonized standards to an apparatus confers on that apparatus a presumption of con formity with the protection requirements of the directive In other words in the case of challenge the responsible national authorities will have to prove that the product is not in conformity with the protection requirements The presumption of conformity is con ferred in regulatory terms only by the use of the national standards transposing a har monized standard CHAPTER 4 Notified Bodies and Certification Always do right This will gratify some people and astonish the rest Mark TWAIN Notified Bodies and Third Parties Common European laws and standards are a good start toward harmonization but mutual recognition of tests and certificates is necessary to create the requisite trust for total harmonization Mutual recognition of test reports and certificates of one member state by another is the overriding requirement A test is considered equivalent if performed by an accredited testing body on the basis of uniform assess ment criteria Accredited bodies are listed in the OJEC as notified bodies safety competent bodies EMC or referred to in general terms as third parties As stated in the OJEC the testing procedures may be undertaken by specialist third parties i e testing laboratories and certification bodies These laboratories and bodies can in turn be evaluated as to their technical competence by a third par
195. quipment enclo sure and to a person or ground 3 5 mA maximum for movable products e Capacitor discharge Measures the stored charge residual voltages on capacitors after a specified time 1 or 10 sec to determine electric shock potential after power disconnection Temperature rise Used to isolate any components plastic parts and touchable surfaces that may attain excessive temperatures or exceed the allowable limits e Stability and impact Tilt tests 10 and side top force tests are performed to ascertain the stability of equipment Impact and or drop tests determine the mechanical strength of products Abnormal operation and fault conditions Tests to limit risk of fire and electric shock from the equipment Various abnormal operation and fault conditions are applied such as electrical shorts opens component failures mechanical faults blocked vents and overloads The equipment s tempera tures and electrical outputs are monitored during these tests The product 114 CE MARKING HANDBOOK must remain safe during and after the tests but is not required to still be in working order after testing e Creepage and clearance Measurement of the minimum allowed distances between various circuits such as primary to secondary primary to ground and within primary Creepage and clearance distances between various cir cuits or parts such as PCB traces components transformer windings and wiring shall not be less than the mini
196. r e Member state national requirements PTT VBG ZH DIN VDE not addressed or referred to or Essential Requirements of the relevant European directive s not considered To stay competitive in the world market and strive for the highest levels of safety the European manufacturers and standards and testing bodies have been very willing to accept new ideas In addition to Europe s strong shock protection philosophy the UL flammability and enclosure requirements have now been incorporated into their standards making the EN TEC standards truly world class safety requirements The good news is that the United States is moving in the direction of EU standards and may eventually adopt them but there s a long way Quality and Enforcement 75 to go Unfortunately it will take some time for North America to understand the European safety philosophy of shock protection and accept their interpretations just as it has taken time for Europe to understand the U S flammability concepts Change takes time as the following witticism suggests The United States is going to the metric system but is getting there inch by inch The Quality and Safety Mindset Exporters should be aware that the German market is the single largest mar ket in Europe and amounts to approximately one third of the entire European Union The German economy is rich sophisticated mature and its people expect quality and safety in the products they buy and sell T
197. r L2144 Luxembourg tel 011 352 29291 fax 011 352 292942763 145 146 CE MARKING HANDBOOK European Commission Guidelines Guide to the Implementation of Community Harmonization Directives Based on the New Approach and Global Approach e Guidelines on the Application of Low Voltage Directive 73 23 EEC Amended by the Directive 93 68 EEC Guidelines on the Application of Council Directive 89 336 EEC of 3 May 1989 on the Approximation of the Laws of the Member States Relating to Electro magnetic Compatibility Community Legislation on Machinery Comments on Directive 89 392 EEC and Directive 91 368 EEC e Machinery Useful Facts in Relation to Directive 89 392 EEC Newsletters and Information SAFETY and EMC ERA Technology Ltd VDE Certification VDE Institute Cleeve Road Leatherhead Surrey Merianstrasse 28 KT22 7SA UK D 63069 Offenbach Germany tel 011 44 1372 367014 tel 011 49 69 8306 0 Institute or fax 011 44 1372 377927 011 49 69 8306 224 publication e mail pub sales era co uk fax 011 49 69 8306 555 or 777 APPROVAL M amp M Business Comm EUROPE LINK Single Market Lime Tree House Lime Tree Walk Ventures Sevenoaks Kent TN13 1YH UK 87 Rue Faider tel 011 44 1732 746616 B 1050 Brussels Belgium fax 011 44 1732 746617 tel 01 1 322 537 2603 e mail cemark approval cix co uk fax 01 1 322 537 1078 e mail europe link skynet be Index A Access areas opera
198. r member states Where the Com mission concludes that the measure is not justified it shall immediately inform the member state that initiated the action Member states may adopt emergency measures when a product poses a seri ous and immediate risk In this case the Commission with the assistance of a Safety Committee and the member state cooperate to expedite the actions according to the urgency of the matter The Committee s opinion shall be delivered to the Commis sion in a timely matter not to exceed one month The Commission shall then adopt the measure and the member states shall take all necessary measures to implement the decisions within ten days Measures requiring the withdrawal of a product from the market shall consider the need to encourage distributors users and consumers to contribute to the implementation of such measures The member states and the Commission shall not disclose information obtained for the purposes of this directive except for information relating to the safety properties of a given product that must be made public to protect the health and safety of persons Parties concerned with a decision involving a product restric tion may challenge any decision before the competent courts Directives and Procedures 21 Any decision taken by virtue of this directive shall be without prejudice to Product Liability directive 85 374 EEC and without prejudice to the assessment of the liability of the party concern
199. r of the product other professionals in the supply chain insofar as their activities may affect the safety properties of a product placed on the market Distributor shall mean any professional in the supply chain whose activity does not affect the safety properties of the product FIGURE 2 2 General Product Safety Terms When there are no specific Community provisions for safety of a product i e EU laws and standards a product may be deemed safe when it conforms to the spe cific rules of national law of the member state 1 e national laws and standards In the absence of Community and national rules for safety then conformity may be based on national standards that are equivalent to a European standard or where they exist to Community technical specifications or failing these member state standards or codes of good practice in the sector concerned or to the state of the art and technol ogy to the safety that consumers may reasonably expect see Standards in Chapter 3 20 CE MARKING HANDBOOK Even when a product is in conformity with the relevant standards authorities are not barred from taking appropriate measures to impose restrictions to marketing of a product or require its withdrawal where there is evidence that despite such con formity it is dangerous to consumers see Standards and Essential Requirements in Chapter 3 The member state authorities have the necessary powers to Art
200. r provisions of the directives e Provide technical interpretation and applicability of standards e May assess manufacturer s technical file and documentation Determine alternatives when no standards exist or other criteria used for conformity to ERs and Test sample products for conformity and award Approval Marks with ongoing surveil lance of production to visibly demonstrate product quality and increase marketing advantage Guidelines for Notified Bodies Shall meet legally binding criteria set out in the annexes to the directives Notified bodies are listed in the Official Journal of the European Communities Member states should accept test reports and or certificates of all notified bodies Testing may be subcontracted to other laboratories under the direct supervision of the body and Notified bodies should reside in one of the EU member states FIGURE 4 1 Notified Body Rules The European Commission has proposed a set of conditions to facilitate mutual recognition e Use common European standards ENs to replace national standards e Manufacturers can establish as much as possible quality systems that are certified by accredited bodies Testing and certification bodies can be accredited to EN 45000 standards so that manufacturers can rely on independent and qualified testing reports and certifications e Certification bodies of the various countries agree on standard
201. reports provide the ultimate defense of due diligence should a product s conformity come into question Since the meaning of safety varies between individuals and depends on our point of view I have purposely left the definition of safety till the end With a thor ough knowledge of safety we can now answer the question that has been the topic of many discussions What is a safe product The General Product Safety Direc tive defines a safe product as any product which under normal or reasonably foreseeable conditions of use does not present any risk or only minimal risks com patible with the products use considered as acceptable and consistent with a high level of protection for the safety and health of persons Also as stated in the Prod uct Liability Directive a defective product is one that does not provide the safety which a person is entitled to expect taking all circumstances into account Along with the formal interpretation of safety mentioned above my defini tion should also be considered Safety means putting consumer protection first and manufacturing products that conform to harmonized standards as the minimum criterion In other words meeting all the relevant harmonized standards is the minimum acceptable level and the manufacturer may actually have to go beyond them to 1 satisfy the essential requirements of the directives 2 meet the latest state of technology and 3 ach
202. rer s Address Importer s Name Importer s Address Transparency Projector Newview NVIZXYZ 1995 73 23 EEC and 89 336 EEC EN 60335 2 56 1991 EN 55014 1993 EN 60555 2 3 1987 EN 50082 1 1992 ABC GmbH Street City Postal Code XYZ Imports Co Street City Germany We hereby declare that the product specified above conforms to the above mentioned directives and standards Notice This Declaration of Conformity is supported by the attached safety EMC approval certifications numbers 9512345 and V9554321 issued by TUV Rhein land a European certification body Signature name title location date FIGURE 2 7a Sample Declaration Overhead Projector The CE marking is not a quality marking The CE marking is not for components some exceptions see Components in Design Guidance in Chapter 6 e The CE marking is based on compliance with EU directives ERs and standards ENs use of non European requirements or standards may require the involvement of an EU notified body Directives and Procedures 35 Declaration of Conformity Manufacturer s Name ABC Co Manufacturer s Address ABC Street Detroit MI 90061 USA declares that the product Product Name Laser Printer Model Number 5432X conforms to the following standards Safety EN 60950 EN 60825 EN 55022 Class B EN 50082 1 using EN 61000 4 2 IEC 801 2 EN 61000 4 3 IEC 801 3 EN 61000 4 4 IEC 801 4 The pr
203. reventing the test fingers entry shall be tested by a 30 N force from a straight unjointed version of the test finger When it is not possible to make hazardous moving parts directly involved in the process completely inaccessible and where the associated hazard is obvious to the operator a warning may be considered adequate protection under certain condi tions see next section Warnings Where the possibility exists that fingers jewelry clothing hair and so on may be drawn into the moving parts a method must be pro vided to stop the moving part and shall be placed in a prominent visible position and accessible where the risk is highest The edges and corners of enclosures shall be rounded or smoothed to prevent cutting hazards to operators Furthermore enclosures handles knobs and the like shall have adequate strength to withstand rough handling during normal use and pass the relevant tests as described in the standards Depending on the product and possible hazards the tests may include force tests steel ball impact test and drop tests refer to standards Parts shali be adequately secured so that should any wire washer spring screw nut or similar part fall out of position or come loose it cannot reduce the dis tances over the reinforced or supplementary insulation levels specified in the stan dards As mentioned parts fixed in place by screws or nuts with self locking washers or other means are not liable to come loose and sol
204. ring or fault detection are preferred and in some cases mandatory Testing nonapproved compo nents CE is not an approval to verify their conformity or nonconformity is the higher risk of failure alternative and usually costs considerably more time and money E Transformers Safety and isolating transformers are frequently used in electrical and electronic products and machines Transformers are a common cause for noncompliance e g if nonapproved The major reasons for noncompli ance are overheating and construction Tests and construction requirements are detailed in the relevant equipment standards and or transformer standards EN 60742 IEC 742 Transformers that comply with EN 60742 usually are in compliance with the transformer requirements contained in the equipment standards The standards have strict construction and testing requirements that are sometimes overlooked by transformer manufacturers or machine builders who source them For example the standards require that transformers must be protected against overheating during a short circuit and while under an overload condition The standards limit the allowed temperature rise in transformers during normal conditions and in the event of an internal or external fault Some common problems with nonapproved transformers are displacement of windings improper wire terminations inadequate creepage clearance prim to sec loose parts bridging prim to sec low grade or improper class of
205. rity of the action depends on the situation and nonconformity of the product Direc tive 92 59 EEC replaces 89 45 EEC and incorporates its system of rapid exchange of information on dangers arising from products at national and Euro pean levels See Figure 2 2 for safety terms In addition to supplying safe products producers must also provide consum ers with the relevant information to assess the inherent risks of the product where risks are not immediately obvious without adequate warnings Such warnings however do not exempt any producer from compliance with the other provisions of this directive Based on the information in their possession distributors shall act with due care to ensure safety compliance in particular by not supplying products that they know or should have presumed do not comply with the safety requirements The producers and distributors themselves must be informed of the risks products pose and adopt measures to enable them to take appropriate action including if neces sary withdrawing the product in question from the market Products must be marked and traceable for monitoring purposes to investigate complaints keep distributors informed and so on RA When a product has been proved dangerous producers must be able to locate the product and withdraw it from the market or if neces sary organize its destruction Directives and Procedures 19 Product shall mean any product intended for consumers or likely
206. rk ET ae ee en OR eee ee Seen EE eee i ee SE a Se es Sea a ene ee Sn Pe tt ee i i ee ee ee B ne ee E e ERD S a na ee Oe eh ee a a er a eee eee ee ge Ee eB 8 ie A ea a F ee ee ee a es eee oo ea eo rn ese ei ee a ae eee eee Je Se ee signature and date of TUV engineer city state date TUV Rheinland of North America Inc signature of applicant manufacturer NOTE TUV CDF modified for clarity CDF formats may vary FIGURE 6 4 Constructional Data Form later date by simply adding additional pages to the CDF This product change is known as an alternate construction If the alternate or replacement part is simple and has similar specifications and an EU type approval mark the change may involve only paperwork depending on the component and its application Substitu tion of more complex components such as transformers or power supplies may require additional testing in your intended application again assuming that the com ponent bears an EU approval mark as a minimum The CDF is especially helpful for factory checks at incoming inspection to verify the components approval marking 98 CE MARKING HANDBOOK before accepting them into stock The CDF can also be referred to during production to verify that manufacturing has assembled the proper components into the product and allows inspectors an easy means of checking for the proper component number or approval mark I
207. rman standards origin Thousands of German standards DIN VDI VDE VBG ZH etc form the basis for the newer harmonized standards EN IEC etc 8 CE MARKING HANDBOOK The legality of standards as the recognized technical rules for equipment safety was first established at the German national level with the GSG which states that equipment shall be constructed in accordance with the generally accepted rules of technology mostly standards This national requirement of uti lizing standards and specifications carries over into the New Approach as the rec ognized method for achieving the presumption of conformity Conformity with the EU harmonized standards EN and their national equivalent i e DIN EN there fore constitutes the basis for a product s presumed technical legitimacy and are in practice the only verifiable path to ensure conformity limit the producer s risks and liability and meet the authority s and consumer s expectations Some people believe that the reason for the popularity of German safety approvals such as the GS Mark is that approvals were mandatory in Germany After all over 100 000 different products bear the GS Mark GS Safety Tested Approvals and marks have however never been mandatory by German law for the vast majority of products and machines Their popularity is driven by expectations in the marketplace from the product users consumer groups insurers and employ ers These high expect
208. role is to provide conformity assessment and product certification for producers in a premarket capacity Market surveillance of products whether at the marketing and distribution stage or at the marketplace is the responsibility of the public authorities In some member states the notified bodies and the surveillance authorities come under the same authority and lines of responsibility are organized to ensure that the two activ ities are separate and independent Market surveillance may be performed at the national regional or local level including the customs authorities When a prod uct s conformity is in doubt the authorities may resort to testing the product them selves at either their own testing facility or at those of a notified body If they are 56 CE MARKING HANDBOOK testing at a notified body s facility the final judgment is determined by the surveil lance authorities not by the notified body Testing Certification and Approval Marks With respect to testing laboratories certification and inspection bodies There is an important role in ensuring conformity building confidence and protecting public interests It has been estimated that there are over 10 000 testing laboratories and 1 000 certification bodies in Europe of varying capacity legal status and reputation Testing certification and inspection may diminish the risks and hence the likelihood of dam ages which in turn reduces the insurance cost
209. ropriate action Accreditation bodies are independent national accreditors who evaluate testing and certification parties according to recognized norms After a third party is found competent in a member state such as in Germany the accreditation body then noti fies the European Commission who notifies the other member states by listing them in the Official Journal These third party testing and or certification bodies are then considered EU accredited third parties or notified bodies Notified bodies are independent testing laboratories and or certification bodies recognized in the European Union to perform tests and issue reports and certificates on conformity These bodies are generally referred to as notified bodies Depending on the directive an accredited body may be referred to as a notified body competent body certification body third party or other see Notified Bodies and Third Parties in Chapter 4 Test reports and certificates issued by accredited bodies attest to a product s or system s conformity to the relevant standards These reports and certifi cates are the basis for mutual recognition of test results and build consumer confi dence in a product s conformity Certification and approvals are statements by an impartial accredited body that a product or service fulfills specific requirements such as directives and stan dards Certification may be mandatory as is the case for some regulated products Annex IV machines te
210. rous companies are rapidly upgrading their products before enforc ers can conclude their investigations ref Approval UK Mar Apr 1997 pp 4 5 In addition products sometimes meet the EMC limits with minimal margins it s good enough and manufacturers start CE marking and shipping without keeping in mind that marginal products oftentimes fall out of compliance after they are put into production because of manufacturing differences and design changes The EMC directive requires spot check testing of products after they are put into pro duction to verify ongoing conformity but this retesting requirement is sometimes forgotten Products on the market for some time become easy targets for market surveillance authorities that realize that reverification testing for ongoing EMC conformity is only sporadically performed by some manufacturers Quality and Enforcement 79 Low Voltage Directive LVD 73 23 EEC CE Marking by 1 1 97 electrical products 50 1000Vac 75 1500Vdc If a member state prohibits a product to be marketed for safety reasons such as nonconformance with or faulty application of standards or failure to comply with good engineering practice the member state shall immediately inform the other member states If CE marking has been affixed unduly the manufacturer or importer shall be obliged to make the product comply Where non compliance continues the member state shall restrict or prohibit its sale or ensure tha
211. rtification The accreditation competence and quality of third party testing and certification laboratories are pro moted through the EN 45000 standards with their recognition granted by the various EU laboratory accreditors i e DAR in Germany The product s quality is shown by the various approval certificates and marks issued by these EU accredited bodies see Notified Bodies in Chapter 4 65 66 CE MARKING HANDBOOK Within the European Conformity safety EMC context three types of quality assessments are addressed in terms of the entities they relate to 1 Factory quality The manufacturer s system 2 Laboratory quality The third parties testing competence 3 Product quality The product s safety EMC conformity Certification of product quality by third parties is not mandatory for the vast majority of factories and products however certification with approval mark on the product is advisable because of customer expectations All three quality types fac tory laboratory and product quality although coexisting are in reality distinct spheres of work with assessments performed by separate groups of experts To ensure customer acceptance for factory and product quality manufacturers require independent verification through various certification schemes In the first type fac tory quality an accredited party will assess a manufacturers facilities and proce dures according to the ISO 9000 series and award a certificate
212. ructions and Languages Flammability of Materials Electrical Safety Testing Production Tests Additional Requirements for Machinery Protective Measures Mains Disconnect Switches Emergency Stop Switches Fault Tolerant Components and Safety Circuits Transformers Motors Wiring Protective Earth Access Areas Enclosures Functional Markings Item Designations Warning Symbols Manuals Technical Documentation OZZPAS Fr romm Design Guide for Safety Conformity 89 1 Component Safety and Liability Any item that is used in the composition of or intended to be built into end products or machines is called a component Products are stand alone equipment that are comprised of components and are ready to use by an operator With regard to equipment safety there are two types of safety sensitive components 1 Critical components are any components that may influence the safety of a product such as those that operate at mains supply 120 230 400 Vac or hazardous voltages gt 50 Vac or 60 Vdc Examples of critical components are inlets filters switches motors circuit breakers power supplies and transformers Components that may operate at lower voltages i e 12 or 24 V and may affect safety are also considered critical components and examples include emergency stop switches door interlocks relays second ary fuses thermal cutouts fans and sensors 2 Safety components as opposed to
213. s The specific technical rules tests and pass fail limits for safety and EMC are detailed in the relevant harmonized standards There are several ways for product and machine manufacturers to show com pliance with the European directives However only one way presumes conformity the use of harmonized European standards This is why I strongly recommend the application of harmonized standards also known as European Norms ENs Stan dards play an important role in European Union safety EMC compliance for products and machines Standards become valid in Europe after they are published in the Offi cial Journal and are transposed into member states national standards The ENs are listed or appended to the directives themselves LA Focus on the standards to achieve the presumption of conformity Some directives such as the Global Approach to Certification and Testing state that a manufacturer s equipment must meet the ERs of the directive and that the use of harmonized standards is voluntary The voluntary clause dates back to the early white papers and basic directives when there were as yet few pub lished standards for machinery The voluntary concept was instituted to allow the use of other standards such as IEC or national standards until the ENs were pub lished in the OJEC This has now changed with numerous EN and IEC standards available 12 CE MARKING HANDBOOK The directive on quality and conformity assessment says
214. s etc 4 Product Assess and test product per standard s etc All member states should establish easily identifiable and effective sur veillance authorities and experts A proactive approach to market surveillance should be promoted to limit the risks of dangers from nonconforming products The objectives of market surveillance must be active and effective enforcement rapid communication on defective products and equal protection for all citizens Just as standards are the foundation for safe product design so is effective mar ket surveillance the cornerstone for securing consumer confidence in the Single Market Enforcement The Product Liability Directive 85 374 EEC on victims rights states that a product must meet a high level of safety that the consumer may reasonably expect It is generally understood that harmonized standards are the minimum safety criteria However a product s compliance with the harmonized standards does not always guarantee a safe product The manufacturer may have to exceed these requirements to make a truly safe product one that also meets the customer s expectations Doing anything less may put the consumer at risk and increase the manufacturer s likelihood of damages Strict liability was established in the European Union to protect consumers users and operators from defective products Directive 85 374 EEC changes the old approach of proving negligenc
215. s thus per mitting mutual recognition of tests and certificates Accreditation at the European level is a relatively new concept and dates back to the early 1980s Accreditation means the recognition of the competence of a labo ratory certification or inspection body by independent accreditors The accredita tion bodies are typically sanctioned by a member state government to perform audits of testing and certification institutions The audited body must be able to demon strate that it meets the criteria described in the annexes to the directives to become recognized at the state level and notified to the European Commission and the mem ber states The bodies that are notified are designated to carry out conformity assess ment as set out in the directives As an assessment technique accreditation is an Notified Bodies and Certification 55 important tool to generate and maintain confidence in these bodies just as certifica tion is for products Accreditors in Germany for both the regulated mandatory certification and nonregulated voluntary certification sectors are united under the German Accredi tation Council DAR In the nonregulated sector the Sponsoring Association for Accreditation TGA is an association of German industry commerce insurance sectors and other associations The TGA is responsible for the inspection of testing laboratories and certification bodies The TGA is joined by the club of European accreditors wh
216. s Fault tolerant components and properly designed safety circuits are necessary to ensure safe and reli able machine control refer to EN 954 364 292 1050 60204 1 etc Common terms associated with these special machine components are control reliable fault tolerant and fail safe which means that if a failure occurs single fault it will always fail to a safe condition e g fail safe The machine s circuit design and components must ensure user protection from all safety hazards such as moving parts or high voltage The requirements for these highly critical components go beyond the requirements for the typical critical components both of which must be met for machinery All compo nents within a safety circuit are of special concern and it s these components such as electromechanical relays contactors guard door interlocks and E stops switches that are invariably the weak point of the circuit Components in this category have addi tional requirements that must be met for safe control reliability Refer to the proper standards for these special components such as EN 348 947 50100 and 60204 1 118 CE MARKING HANDBOOK To illustrate some common misconceptions a few examples of compliant and noncompliant industrial type components are discussed in the next sections Fault tolerant components that have been EU type approved for proper classification such as positive opening guarded actuator redundancy cross monito
217. s are permitted E or E 3B 3C M Warning Symbols Warnings are required for all hazards to notify personnel the duty to warn such as on any enclosure panel or door that does not clearly show that it contains a hazard A black triangle and pictogram on a yellow background in accordance with the standards shall be used The service persons must also be warned of any possible hazards before they access a compartment such as high voltage or energy moving parts high temperature or laser radiation Addi tional warning symbols may be required on internal covers and adjacent to hazards within the compartments to protect against accidental or inadvertent contact See also Section 15 Warnings In some cases a warning may be considered adequate if it is not possible to make hazardous moving parts directly involved in the process completely inaccessi ble and where the associated hazard is obvious to the operator In such a case where fingers jewelry clothing etc can be drawn into the moving parts a warning shall be provided in a visible and prominent position for stopping the moving part An exam ple of where it may not be possible to guard the hazard is the visible moving parts of a paper cutter where hand feeding is required or 3A 3B or 3B 3C oe User protection is paramount Warnings are only permitted when no other means are possible and may not take the place of a safe design For example a MOVIN
218. s stated in the European Commission s Guide to the Imple mentation of Community Harmonization Directives Manufacturers are responsi ble for ensuring that the products they place on the market meet all relevant regulations Where these regulations do not require mandatory certification manu facturers often seek voluntary certification to assure themselves that their products do meet the requirements set by law Opinions and misinformation abound All you have to do is ask a question and you will most likely get conflicting answers To further complicate matters the answer depends on who is asking the question Asked by those involved in the legal technicalities of product design and exportation the most asked question is What do I need to ship products to Europe The answer seems obvious it s the CE marking From the legal point of view the CE symbol and proper documentation are all that s mandatory for access to the European Union in most cases since it is man dated by customs inspectors and enforcement authorities Some manufacturers and marketing professionals overstate the importance of the CE marking by placing far too much emphasis on its importance and elevating its stature to one of covenance By stating to the consumer that their products have the coveted CE approval they expect the buyer to look no further and purchase their products without any independent official evidence of conformity For those involved
219. s were not correctly applied action must be taken against the manufacturer Guidelines on the Application of Council Directive 73 23 EEC LVD Products are presumed to conform to the safety objectives of the Low Voltage Direc tive where the equipment has been manufactured in accordance with technical stan dards which in the order laid down by the directive are as follows European standards EN or HD which are referred to as harmonized standards in the Directive drawn up in accordance with Article 5 by the bodies notified by the mem ber states in fact these are standards made by CENELEC wWhere standards as defined in Article 5 have not yet been drawn up and published the international rules issued by two international bodies the International Commission on the rules for the approval of electrical equipment CEE or the International Electro technical Commission IEC Article 6 1 and published in accordance with the pro cedure laid down in Article 6 2 and 3 and wWhere standards as defined in Article 5 or international standards as defined in Article 6 do not yet exist the national standards of the member state of manufacturer Article 7 The standards referred to in Articles 5 6 and 7 the application of which remains vol untary provide a presumption of conformity for equipment manufactured in accor dance with these standards Alternatively the manufacturer may construct the product
220. sance tripping but the delay may not result in a fire or overheat condition during a fault test Select the lowest value possible according to the actual current not calculated current MA L The rated current of fuses and other protection devices shall be selected as low as possible based on the actual measured input In general for information technology equipment ITE user accessible fuses shall be of a European type IEC 5 x 20 mm whereas internal fuses may be U S sized 3 AG 1 4 x 1 1 4 in or an IEC type Other standards such as for machinery require that all fuses internal or external be readily available for replacement in the country of use For Europe this means an IEC type For smaller fuse types i e 5 x 20 mm there are fuseholders that can hold either U S or IEC fuses in the same fuse holder For larger fuses it may be difficult to source one fuseholder to meet both the U S and IEC fuse sizes Hence circuit breakers are the best option in this case In addition to fuses or circuit breakers thermal cutout and temperature limiting devices are often required to limit temperature rise during fault tests Temperature limiters or cutouts are used where an excess current draw is not sufficient to open a fuse thereby causing an overheat condition Transformers are regarded as tempera ture sensitive and may be subject to dangerous overheating due to a fault during a secondary short or overload Motors may also over
221. se lected values General information S Other conditions may be used whenever doubt exists about the application of Red Yellow Green Blue Monitoring FIGURE 6 9 Indicator Light Colors and Their Meanings power supply units and switchgear assemblies may all be described as items for designation purposes Terminal designations are applied to the conducting parts of an apparatus screw terminal terminal block quick connect tab provided for elec trical connection to the circuits and conductors Aspect is the specific way of select ing information on or describing a system or an object of a system such as What the system or object is doing function viewpoint How the system or object is constructed product viewpoint or Where the system or object is located location viewpoint The item designations and symbols may be placed in a block format with each block consisting of latin letters or arabic figures or both uppercase letters being pre ferred The blocks may be preceded by a prefix sign Prefix signs are used to distin guish the various designation blocks and enable the blocks to be combined in any suitable manner Prefix Sign Location Type Number Function Example Block 1 Higher level function T2 Block 2 Location D126 Block 3 Item aspect K5 Block 4 Terminal 14 126 CE MARKING HANDBOOK Examples A Assemblies subassemblies Amplifier using discrete components magn
222. see Figure 6 2 It is the end product or machine manufacturer who takes confor mity responsibility for the equipment s design and the components they specify Utilizing nonapproved components in the equipment places the end product manufacturer in a precarious position especially with regard to testing documenta tion and ongoing conformity of the components The CE marking is only a self declaration and if the component has no European type approval mark the end product manufacturer may have to do additional testing 1 Testing nonapproved components adds cost time and risk since the component often fails the assessment even when a CE marking or other non European mark UL CSA are present Remember manufacturer s self declarations for products and components have been allowed under the LVD since 1973 and not generally recognized as evidence of compli ance by European testing bodies or enforcement authorities 2 If passing results are obtained in the end equipment for a nonapproved component it may then be used in that model only restricting the compo nent as application sensitive Retesting may be required for the same com ponent in other models 3 Using nonapproved components makes the product manufacturer responsi ble This includes responsibility for the component s design construction documentation and ongoing compliance areas where the end product or machine manufacturer have no real control BA Spec
223. set out the conditions in which a the manufacturer makes his choice as to the most appropriate modules for his production The directives should attempt to leave as wide a choice to the manufacturer in set ting the range of possible choices and avoid imposing unnecessary modules which would be too onerous Notified bodies should apply the modules without undue burden on the economic operators in order to ensure consistent interpretation and application of the mod ules the EOTC or Commission will organize close cooperation between the noti fied bodies Wherever directives allow use of quality assurance techniques for manufacturers they must also wherever possible provide for the possibility of recourse to product certification e Member states shall notify only bodies for operating the various modules which comply with the requirements of the directives and accredited to EN 45000 series e The Commission shall publish lists of notified bodies in the OJEC and it shall be updated and The CE marking accompanied where appropriate by the notified body identifi cation symbol shall be affixed to show that the production phase has been carried out satisfactorily with regard to the requirements of the directives Quality assurance techniques e g ISO 9000 factory quality are not relevant for modules A Aa or B C and may not take the place of the safety EMC directives for product conformity FIGURE 2 5 General
224. st a few For components and products that successfully pass testing a certificate is issued by the EU body giving the manufacturer the right to affix the approval mark In addition to the mark on the component a copy of the certificate may be needed to verify the component s ratings and part number and to bring to light any restric tions for use Some designers and buyers are satisfied if they see the approval mark on the component but it s a good idea to obtain the approval certificate for review and to place in the technical file Always request the approval certificate for complex components such as monitors and power supplies since restrictions may be written on the certificate or in the installation instructions which must be checked for suit ability in the end application Some examples of restrictions that may be found on a power supply certificate are e For use with external fuse rating of For use with forced air cooling of e For vertical mounting only e Isolation system hazardous energy outputs It is important to request the approval certificate to answer all your questions Once you have the certificate you should also verify that e The components part number matches the component number on the certificate The voltage current and other ratings are acceptable for the intended use The appropriate standards have been applied and e Any restrictions for use 3 Construction
225. standards giving effect to a European standard or failing these to standards drawn up in the member state in which the product is in circulation The Product Liability Directive 85 374 EEC Protection of the consumer requires that all producers involved in the production pro cess should be made liable insofar as their finished product component part or any raw material supplied by them was defective e The producer shall not be liable as a result of this directive if he proves that d the defect is due to compliance of the product with mandatory regulations issued by the public authorities To protect the physical well being and property of the consumer the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect e g harmonized or national standards The Conformity Assessment Procedures and Rules for CE Marking Directive 93 465 EEC e The directives must set the range of choices which can be considered by the Council to give public authorities the high level of safety they seek for a given product or product sector These procedures may only depart from the modules when the specific circumstances of a particular sector or directive so warrant Such departures from the modules must be limited and must be explicitly justified in the relevant directive
226. symbol of the manufacturer s declaration Lohbeck FIGURE 4 2 Hierarchy of European Conformity Acceptance 60 CE MARKING HANDBOOK FIGURE 4 2 continued CE marking is the manufac Advantages turers self declaration symbol e CE indicates conformity to customs inspectors indicating conformity with the allowing products to be placed on the market essential requirements of all Ensures free movement of goods within relevant directives The product Community CE marking and declaration of A presumption of conformity exists when conformity is mandatory for products are in conformity with EN standards 4 most products A technical file Disadvantages describing the product design No visible Approval Mark or Certification assessment tests standards Implies conformity with minimum require applied rationale etc shall ments of the Directives and CE is not viewed also be readily available as a quality marking Not for sales marketing or promotional pur poses Authorities and customers may question CE marking based on incident complaint other 4 Terms CE European Conformity EN European Norm EU harmonized standard ER Essential Requirements of the Directives CB Certification Body NCB National Certifi cation Body S N Serial Number tested sample s TRF Test Report Format OJEC Official Journal of the European Communities
227. t comings of design This method is to be employed only as a last resort and when 1 or 2 is not possible Warnings may not take the place of a safe design If a product or machine can be made safe it should be According to the ERs of the directives compliance with the EN standards is defined as the minimum acceptable criteria but in some cases the manufacturer will have to go beyond the standards such as when EN or IEC standard does not exist shall use EU national standard until EN sanctioned Existing standards are inadequate preliminary draft or provisional stan dard may be recognized State of the art meeting the latest state of technology may be required in addition to standards Justified national requirements or exceptions exist Additional marking documentation or translation requirements Ergonomics noise environmental protection other Mechanical in addition to electrical for LVD products or visa versa for machinery Special usage or environment i e industrial area hazardous location EM fields Products safety influenced by EMC EMC tests may also be required for safety compliance Foreseeable use not addressed in standard also consider reasonable misuse Market or customer expectations see Product Liability and General Prod uct Safety in Chapter 2 or Specifics in directives ERs may exceed standards requirements 50 CE MARKING HANDBOOK European standards are the c
228. t s conformity to the EU directives and standards The requirement for certification can come from e Consumers and users who often look for and expect a recognizable approval mark e Distributors who recognize the importance of certification for marketing and to reduce of risks Product manufacturers who require the assurance of accurate testing for components they specify Notified Bodies and Certification 57 e Insurance companies who wish to assess and limit their risks Government departments who wish to ascertain that a product complies with specific regulations e Various institutions and service providers such as banks schools or medi cal institutions Companies whose safety policy dictates a third party attestation to reduce risks and insurance costs It is often the distributor importer or authorized representative who is first called to task if an incident occurs or a product s conformity becomes suspect The Commission s Guide to the Implementation of Community Harmonization Directives Based on the New Approach and Global Approach states Manufacturers are responsible for ensuring that the products they place on the market meet all the relevant regulations Where these regulations do not require mandatory certification manufacturers often seek volun tary certification to assure themselves that their products do meet the requirements set by law Defense of Due Diligence Due diligence means t
229. t Safety Directive 18 22 Generic directives 16 standards 47 48 German model 6 8 Germany accreditors in 55 Global Approach 10 11 Ground continuity tests 115 Grounding 106 7 Guidelines CE marking 33 39 H Harmonization and CE symbol 1 3 definitions and considerations 3 6 accreditation bodies defined 6 approvals 6 authorized representative defined 5 CE marking defined 5 certification and approvals defined 6 components defined 4 declaration of conformity defined 5 directives defined 4 equipment defined 3 evaluation of conformity defined 5 harmonized standards defined 4 manufacturer defined 4 5 national authorities defined 5 6 notified bodies defined 6 presumption of conformity defined 4 product defined 3 4 technical construction files defined 5 technical file defined 5 test reports defined 5 EU European Union 1 3 Europe s approach to total 1 13 German model 6 8 history 6 8 New Approach 1985 8 11 standards versus directives for conformity 11 13 total 137 41 Harmonized standards 3 41 46 defined 4 and minimum requirements 41 Hazardous moving parts 109 Hazards 47 energy 86 fire 70 mechanical 108 10 miscellaneous 87 safety 70 shock 70 71 I IEC International Electrotechnical Commission 11 41 103 108 120 standards 42 46 104 137 Improbability double 103 Indicators 100 101 Information sources 145 46 Instructions 87 110 11 Insulati
230. t another trade barrier but this is not the case since everyone even Europeans themselves must now follow the same rules Further negating the notion of the CE Marking as being a trade barrier is the fact that in the past the member states of the EU had numerous barriers within Europe Each country was setting its own laws and standards and enforcement was not uniformly applied The initial goal of the New Approach was total harmoniza tion of regulations to remove Europe s internal barriers to trade which was later expanded to a broader global approach The objective was to ensure a more even and fair competition among member states and to improve competitiveness with prod ucts coming from outside Europe The total harmonization concept has had a very positive effect in establishing one set of conformity laws standards and procedures to be adhered to universally Furthermore Europe s product standards and assess ment procedures are now recognized internationally by most countries as the world wide standards making total harmonization a truly global approach To the product designer manufacturer exporter and informed consumer the CE marking raises many unanswered questions Understanding the real meaning of the CE marking and what s required to affix it to products can take many hours weeks or months of study Oftentimes with so much conflicting information in abundance those that took the initial steps to understand the CE marking
231. t disconnect device e CAUTION A readily accessible disconnect device shall be incorporated in the fixed wiring for permanently connected equipment without disconnect device Design Guide for Safety Conformity 111 The wording of electrical products instructions and products markings related to safety shall be in a language that is acceptable in the country in which the equipment is to be installed ref EN 60950 EN 61010 1 73 23 EEC 89 392 EEC others Warning symbols must discourage operator access to compartments contain ing hazards and must warn service personnel of potential hazards when the hazard is not evident Safety warnings shall be unequivocal by color shape and size and located as close to the hazard as possible The warning symbols size and colors are described in the relevant product safety and other supportive standards ref EN 60417 EN 60204 1 IEC 1310 1 2 ISO 3461 1 3864 4196 7000 others A trian gle and pictogram distinguishes warning symbols from others that do not pertain to safety The preferred method is to use black and yellow warning symbols without text or signal words so that the safety warning is unambiguous and negates the need to translate text Other colors may be acceptable depending on the product specific standard If signal words and text are used they should be translated into the appro priate languages When hazard symbols are used on the product their meaning must be clearly explai
232. t in compliance with the appropriate European standards the equipment will not benefit from a presumption of confor mity conferred by the use of such standards Manufacturer is the entity responsible for designing and manufacturing a product that is covered by a directive or directives with a view to placing it on the market The manufacturer shall follow the appropriate assessment procedures and is responsible for all aspects of the product s conformity This includes but is not lim ited to the product s design testing reports documentation declaration technical file and CE marking The manufacturer is ultimately liable for the product s Europe s Approach to Total Harmonization 5 conformity and the accuracy of the technical file Manufacturers may if they so choose use an authorized representative for limited delegated responsibilities An authorized representative is the person appointed by a manufacturer to act on its behalf within the EU There is no mandatory requirement to have a authorized representative for most products The representative shall be estab lished in the EU and is the person who signs the declaration holds the technical file and carries out certain tasks required by the directives as agreed upon by the manufacturer Evaluation of conformity is an assessment and is the systematic review to which a product or system fulfills specific requirements i e harmonized stan dards A mandatory assessment a
233. t on the market and signify such by affixing the CE marking Producers beware Placing the CE marking on a product informs users competitors and authorities that the producer is aware of the laws standards and consequences when a product becomes suspect Note This section focuses on key elements of the directive and is only a part Refer to the directives for the complete text The actual wording of the directives is binding Customs Authorities and Border Controls Directive 93 339 EEC on Checks for Conformity with the Rules on Product Safety of Imports states that products may not be placed on the Community market unless they conform to the rules applicable whereas member states are thus responsible for carrying out checks on their conformity Furthermore customs authorities must be closely involved in the market monitoring operations provided for under Community and national rules Customs authorities shall suspend the release of goods or batch and immediately inform the national authorities who shall take suitable action The conditions for suspending products release from customs and notification of the national authorities are e If goods give rise to a serious doubt as to the existence of serious and immediate risks e If customs authorities find that documentation that should accompany the product is missing or e If products are not marked as specified in the Community or national rules on product safety
234. t the EU regulations may be more profitable than the often times endless discussions and meetings within a company about the possible benefits In the end it s the customer s safety concerns that will determine whether the product is a success Also remember that when a product becomes suspect enforcement authorities will most likely refer the product to a notified body for test ing and assessment AS Approval Mark Test Report Sales Success Due Diligence The approval mark on the product and accompanying test report from a noti fied body serve two purposes In regards to safety EMC conformity the test report is the manufacturer s best line of defense if the product s safety is questioned and a reputable approval mark on the product is marketing s best sales tool As the Euro pean Commissions Guidelines on the Application of Council Directive 73 23 EEC LVD states In the case of challenge by the authorities in charge of market surveil lance a report in the sense of Article 8 2 which however is not man datory is considered an element of proof In fact in addition to the three basic conformity assessment measures technical documentation decla ration of conformity and CE marking Article 8 2 provides in the event that conformity is challenged for the possible submission to the market surveillance authority of a report drawn up by a notified body as evidence that the electrical equipment complies with the safety
235. t the prod uct is withdrawn from the market Electromagnetic Compatibility EMC Directive 89 336 EEC CE Marking by 1 1 96 electrical products machinery etc Where a member state ascertains that a product does not comply with the protection require ments it shall take all appropriate measures to withdraw the product from the market prohibit its placing on the market or restrict its free movement and shall immediately inform the Com mission for reasons of noncompliance such as failure to satisfy requirements or the incorrect application of the standards The Commission can then inform the member states and take the appropriate action against the author of the attestation declaration e Machinery Directive 89 392 EEC CE Marking by 1 1 95 includes mechanical and electrical safety When a member state ascertains that machinery bearing the CE marking is liable to endanger the safety of persons it shall take all appropriate measures to withdraw the machine from the market and prohibit its marketing If after consultation with the parties concerned the commis sion considers the measure is justified it shall immediately inform the other member states and the member states shall take appropriate action against whomsoever has affixed the CE marking General Product Safety Directive 92 59 EEC Allows only safe products to be placed on the market and meet a high level of protection of safety Gives member stat
236. tandards v Step 2 Assess equipment according to the Essential Requirements and Harmonized Standards v Step 3 Prepare the Technical File Step 4 Prepare and sign the Declaration of Conformity Step 5 Affix the CE Marking Note All five steps are required whether the manufacturers are completing the process on their own for self declaration or using an accredited EU body for the voluntary or mandatory certification proce dures For certification the EU testing and certification body will perform steps one and two and oftentimes step three FIGURE 7 2 The Steps to European Conformity CE Technical file The manufacturer s technical documentation file supports the CE marking The contents of a technical file generally include the dec laration of conformity name and address of manufacturer product descrip tion and identification list of standards and directives applied design and schematic drawings calculations test reports parts lists manuals and so on Technical files must be readily available and may be requested by enforcement authorities for inspection purposes should a product become suspect or an incident occur 140 CE MARKING HANDBOOK Test report Test reports are technical records on the conformity assessment of a product according to specific standards Test reports are concise accounts that include clause by clause details on the results of a product assess
237. tandards Date of Withdrawal EN standards Draft Standard European Community see EU European Competent Body for EMC European Economic Area European Economic Community European Free Trade Association Essential Health amp Safety Requirements Electromagnetic Compatibility EMC Directive European Machinery Directive Draft European Standard preliminary European Norm European Standard Draft European Prestandard European Prestandard temporary standard European Organization for Testing and Certification 143 144 CE MARKING HANDBOOK ER s EU EUT FCS GS GSG HD IEC ISM ISO ITE IVD LVD MDD MOU MRA NCB OJ OJEC PTT SMT TBM TCF TMP TRF VDE Essential Requirements see EHSR European Union Equipment under Test for EMC Full Certification Scheme Geprufte Sicherheit safety tested German safety mark Geratesicherheitsgesetz Equipment Safety Law Harmonization Document similar to a European Standard International Electrotechnical Commission Industrial Scientific and Medical International Organization for Standardization Information Technology Equipment In Vitro Diagnostic Devices Directive Low Voltage Directive Product Safety Law Medical Devices Directive Memorandum of Understanding Mutual Recognition Agreement National Certification Body Official Journal see OJEC Official Journal of the European Communities Post Telephone and Telegraph for telecom Supervised
238. th and labeling The equipment categories are 1 Handheld equipment Products intended to be held in the user s hand dur ing normal use 2 Movable equipment Equipment that is either 18 kg 39 5 Ib or less in mass and not fixed or that has wheels castors or other means to allow movement by the operator as required to perform its intended use Stationary equipment Equipment that is not movable equipment 4 Fixed equipment Stationary equipment fastened or secured at a specific location 5 Built in equipment Equipment that is intended to be installed in a prepared recess such as a wall Note Built in equipment may not have an enclosure on all sides as some sides may be protected after installation 6 Direct plug in equipment Products intended to be used without a power supply cord the mains plug is an integral part of the product s enclosure and the weight of the product is supported by a socket outlet w 5 Power Consumption It is important to know the equipment s actual power requirements to design the markings and rating labels Calculating the equipment s input is often unreli able Through measurements establish the equipment s power input under normal operating conditions and with all possible loads applied The input is verified by measuring the input current amperage to the product Measure and record the product s input power at the desired operating voltage which is typically 230 Vac or 400 Vac
239. that conform to the European har monized standards are presumed to comply with the essential requirements of the directives Lt Compliance with the Essential Requirements via European stan dards is generally considered the minimum acceptable criteria CE Marking Directive 93 68 EEC states that the choice of conformity assess ment procedures must not lead to a lowering of safety standards of electrical equip ment products which have already been established throughout the Community Alternatives to European standards are possible in the case where no European har monized standard exists Conformity to International standards i e IEC or Euro pean national standards i e DIN BS NF is sometimes an acceptable alternative but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria The General Product Safety Directive 92 59 EEC allows the use of EU national standards when no European harmonized standards exist This alternative may be needed as a transitional measure until a European standard is published see General Product Safety in Chapter 2 This approach is not recommended when European harmonized standards exist especially if a product becomes suspect since Europe s Approach to Total Harmonization 11 one can expect the national enforcement authority will use the EU harmonized stan dard or their national
240. tion of conformity must contain the following elements reference to the harmonized standards see directive for other elements 93 68 EEC No L220 p 21 The Machinery Directive 89 392 EEC Where a national standard transposing a harmonized standard the reference for which has been published in the Official Journal of the European Communities covers one or more of the essential safety requirements machinery or safety components constructed in accordance with the standard shall be presumed to comply with the relevant essential requirements In absence of harmonized standards member states shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national stan dards and specifications that are regarded as important or relevant to the proper imple mentation of the essential safety and health requirements Contents of the EC declaration of conformity for machinery 1 where appropriate a reference to the harmonized standards where appropriate the national standards and specifications used see directive for other elements The Electromagnetic Compatibility EMC Directive 89 336 EEC L To facilitate proof of conformity with these requirements it is important to have harmo nized standards at European level concerning electromagnetic compatibility so that prod ucts complying with them may be assumed to comply with the prote
241. to EN 60204 1 and other applicable standards must be performed by qualified safety per sons Additional requirements may apply depending on the machines use environment and machine safety standards 2 Alternatives to the values are permitted if the pass fail criteria is described elsewhere in the test record 116 CE MARKING HANDBOOK The essential factors relating to electrical aspects of machines are to promote 1 safety of persons property and machine 2 consistency of control response and 3 ease of maintenance v Safety of the operator and service personnel is most important High performance should not be obtained at the expense of these essen tial factors A Protective Measures Protective measures shall be employed to effectively 1 Protect the operator from shock 2 Protect the equipment from overload conditions The equipment design and overall enclosure shall provide protection of per sons against electric shock from e Direct contact All measures for protection of personnel that may arise from direct contact with live parts of the electrical equipment e Indirect contact Protection of personnel from hazards that may arise in the event of an insulation failure single fault between live parts and exposed conductive parts Protection against direct contact with live parts is fulfilled in a number of ways such as enclosures guards interlocks insulation and the use of SELV or PELV circui
242. to be used by consumers supplied whether for consideration or not in the course of a commercial activity and whether new used or reconditioned Safe product shall mean any product which under normal or reasonably foreseeable conditions of use does not present any risk or only minimal risks compatible with the products use considered as acceptable and consistent with a high level of protection for the safety and health of persons taking into account the characteristics of the product including its composition packaging instructions for assembly and maintenance the effect on other products where it is reasonably foreseeable that it will be used with other products the presentation of the product the labeling any instructions for its use and disposal and any other indication or information provided by the producer the categories of consumers at serious risk when using the product in par ticular children Dangerous product shall mean any product which does not meet the defini tion of safe product Producer shall mean the manufacturer of the product within the Community and any other person presenting himself as the manufacturer by affixing to the product his name trademark or other mark or the person who reconditions the product the manufacturer s representative when the manufacturer is not estab lished in the Community or if there is no representative within the Com munity the importe
243. to either the manufacturer s reputation to the strength or weakness of national testing certification and inspection infrastructures to national political traditions in respect of the role of legislation and to different national attitudes towards product liability OJEC 89 C 267 12 Lu If a product becomes suspect enforcement authorities will most likely refer the product to a notified body for testing and assessment The manufacturer s best line of defense is a test report and approval mark from a notified body Product safety EMC claims of conformity for sales and marketing often raise more questions than they answer and may not be supportable Unsubstantiated claims are in abundance Watch out for the following statements e Product designed to meet e In accordance with e Complies with standard IEC e ISO 9000 certified e Lab evaluated to EN 45001 e Tested in association with e Laboratory recognized by e Testing witnessed by Tested by U S lab for CE e Submitted for approval e The test report is on file but we can t let you see it e The CE Mark is all you need trust me e CE certified ask me no questions e CE approved Pl tell you no lies 68 CE MARKING HANDBOOK Consultants Benefits and Limitations Consultants and outside laboratories may be helpful
244. tor 120 Accreditation at European level 54 55 bodies defined 6 Accreditors in Germany 55 Acronyms EMC 143 44 Appliances 84 Approval defined 6 73 Approval marks 56 57 67 certificates 60 63 defined 140 on products 58 60 Areas European Economic 37 operator access 87 120 service access 87 Art state of 49 52 Aspect defined 125 Assembly defined 124 Assessment conformity 45 Authorities customs 26 27 national 5 6 national enforcement 42 Authorized representative defined 5 B Basic directives 15 insulation 86 part defined 124 standards 47 48 Block format 125 Blocks terminal 104 Bodies accredited 6 credibility and reputation of 60 goal of accredited 53 notified 6 53 63 testing and certification 55 Border controls 26 27 Buyers beware 69 Cc CDF constructional data forms 88 95 98 CE mark 35 CE marking 1 2 35 37 41 credibility at risk 135 36 defined 5 138 guidelines 33 39 not intended for marketing or sales 66 written questions concerning 37 39 CE symbol and harmonization 1 3 Certificates 69 approval mark 60 63 of Conformity 33 defined 56 140 Certification 53 63 and approvals defined 6 bodies and testing 55 147 148 CE MARKING HANDBOOK Certification continued mandatory 30 31 product 137 41 voluntary 31 57 Certifications selling affiliations over 68 69 Circuit protection 107 8 Circuits safety 117 18 separation of 105 6 Classif
245. tors against e Excessive temperature rise Rapid destruction during start up or in the locked rotor condition e Unacceptable reduction in service life e Nuisance tripping during normal operation Overload protection is recommended for all motors especially coolant pump motors and shall be provided for each motor rated at more than 0 5 kW Continu ously operating motors over 1 kW shall be protected against overloads and against a stalled rotor state with built in thermal sensors typically employed EN 60034 11 The use of appropriate protection devices for special duty motors e g rapid traverse locking rapid reversal is recommended For motors with ratings less than or equal to 2 kW overload protection may not be required U S wire nuts are not permitted for wire connections Fixed terminals for wire termination within a motor junction box is the preferred method If the motor is nonapproved as is sometimes the case for larger motors additional testing and review will be necessary to verify conformity of the motors construction and its pro tection devices LLI Motors shall meet the construction requirements spacings materials etc employ fixed terminals no wire nuts for wire connec tions utilize effective protection devices and pass the relevant tests G Wiring Wiring conductors and cables shall run from terminal to ter minal without splices no wire nuts and the terminations of multicore cables ade quately supp
246. trical products appliances machinery etc immunity and emissions 1989 Machinery Directive 89 392 EEC issued for machine safety 1992 Treaty of Maastricht for one policy of defense foreign affairs citizenship and currency 1993 CE Marking Amendment 93 68 EEC issued for CE marking declaration and technical file 1993 Treaty on European Union completes the process of the internal market policies FIGURE 1 1 A History of European Directives Under the New Approach the entire process was placed on a fast track forcing the release of many new directives and standards as well as amendments to existing directives and standards to bring them in line with the New Approach This approach mandates a total harmonization concept through the implementation of European laws known as directives The purpose of the New Approach is to establish one set of regulations directives standards for all to follow to ensure the free movement of goods persons services and capital The rules are therefore to be consistent and applied uniformly throughout the Community When the regulations are applied properly manufacturers may affix the CE marking to products which allows prod ucts to be placed on the market 10 CE MARKING HANDBOOK Another new strategy called the Global Approach is a supplement to the New Approach establishes uniform conformity assessment procedures and rules for the CE conformity marki
247. ts The following measures shall be considered to protect the equipment from Overcurrent arising from a short circuit e Overload currents e Abnormal temperature Loss or reduction in supply voltage e Overspeed of machine elements The equipment and personnel protection measures and device types usage arrangement and operation of devices are described in EN 60204 1 and other related standards rz All fuses used in machines internal and external must be of an European IEC type U S fuses are not readily available throughout Europe despite what we hear Circuit breakers may be the best option B Mains Disconnect Switches Mains disconnect switches are required on all machines to isolate the entire electrical equipment The OFF position must be lockable IEC symbols for ON OFF positions must be present and meet the relevant EU standards for construction and operation which is assured if the device Design Guide for Safety Conformity 117 is EU type approved as a mains disconnect or as a combined E stop disconnect device rotary lockable type red yellow etc Star delta reversing multi pole and U S knife type pull down switches are not acceptable The switch must be capa ble of switching the stalled current of the largest motor and at the same time total currents of remaining loads C Emergency Stop Switches Emergency stop E stop switches shall be provided on every machine to avoid injury to personnel and the surr
248. ty accreditation body and hence be accredited a company may entrust systematic or sample product testing to an independent body third party OJEC 89 C 267 11 There fore the terms third party and accredited body notified competent have the same meaning in Europe and should not be confused with nonaccredited parties such as consultants outside laboratories U S agencies manufacturers and others that have not undergone an official evaluation by an EU accreditor and listed in the OJEC The goal of the accredited body is to protect the health of the consumer and the safety of the environment with special emphasis placed on the well being of the consumer Figure 4 1 Placing consumer protection first also limits the product manufacturer s risks When called upon the testing and certification bodies must accurately assess equipment according to established European norms as the mini mum criteria confirming with such by the issuance of test reports and certifications recognized by all concerned parties Doing anything less may put both the consumer and manufacturer at risk 53 54 CE MARKING HANDBOOK Role of the Notified Bodies Ensuring conformity building consumer confidence and protecting public interests e Provide facilities for conformity assessment on the conditions set out in the directives e Issue test reports and certificates on conformity Provide guidance on the essential requirements or othe
249. ty classification of 99 ERs essential requirements 1 2 4 10 11 34 42 69 EU European Union and CE symbol 1 3 focus on shock hazards and construction 12 and U S differences 69 75 Europe approach to total harmonization 1 13 and consumer expectations 75 EMC enforcement in 78 79 plug and socket types in 103 4 European Conformity 41 definitions 138 40 approval marks defined 140 CE marking defined 138 certificates defined 140 directives defined 138 standards defined 138 technical file defined 139 test reports defined 140 European laws 15 18 European level accreditation at 54 55 European manufacturers accepting new ideas 74 75 European safety and EMC acronyms 143 44 and fire 71 European standards 42 44 centerpiece of total harmonization process 50 compliance with 50 and minimum criterion 42 understanding requirements 71 72 European Union See EU European Union Evaluation of conformity defined 5 Evidence of conformity 136 F Factory quality 65 67 Fail safe defined 103 150 CE MARKING HANDBOOK Fault tolerant components 117 18 defined 103 Files technical 5 31 32 technical construction 5 Finland product safety enforcement in 80 Fire and European safety 71 hazards 70 and tests 71 72 Fixing double 87 Flaming oil test 71 Flammability of materials 111 12 and testing 12 Functional markings 121 23 Fuses 108 Fusing insulation safer than 98 G General Produc
250. ty standards are in general intended to prevent injury or damage caused by the following hazards Electric shock Energy e Fire e Heat e Mechanical e Radiation e Chemical e Materials e Others Some key terms and definitions are essential in understanding the European safety philosophy Electric shock is caused by current passing through the human body Even currents in the milliamp region can cause a reaction in people resulting in injury from an involuntary reaction such as a quick movement that can cause a person to fall or to strike a secondary object Higher currents may cause more damage Volt ages less than 40 V peak or 60 Vdc are not regarded as dangerous assuming that parts that users can touch are properly grounded or insulated Electric shock can occur when there is a breakdown of insulation between parts of normally hazard ous voltage and SELV circuits or accessible conductive parts SELV Safety Extra Low Voltage is a safe secondary circuit that may be touched by the user i e connector I Os wiring for peripherals some exposed PCB traces SELV circuits are so designed and protected that under normal and single fault conditions their voltage does not exceed a safe value such as 42 4 V peak or 60 Vdc depending on the standard applied Hazardous voltages gt 50 Vac 60 Vdc and SELV circuits user touchable must be properly segregated distance or separated by earthed screens metal or isolated
251. ucer s liability The EU believes such limits inappropriate but it recognizes that member states may devi ate from that position because of differing traditions The directive lets member states limit liability but only if the limit is high enough to guarantee adequate pro tection for the user Figure 2 4 shows a comparison between German and European liability laws Y The producer is liable for damage caused by a defect in the prod uct The injured person only needs to prove the damage the defect and the casual relationship between the defect and the damage To achieve effective protection of consumers no contracts are allowed to reduce the producer s liability The liability of the producer arising from this direc tive may not in relation to the injured person be limited or excluded by a provision limiting his liability or exempting him from liability No contractual derogation i e between producer and user should be permitted as regards the liability of the producer in relation to the injured person In a few cases producers should be able to free themselves from liability if they furnish proof of certain exonerating circumstances The contributory negli gence of the injured person may be taken into account to reduce or disallow such lia bility Producers shall not be held liable if they prove That they did not put the product into circulation or That it is probable that the defect did not exist at the time or
252. ucts must bear the CE marking as of January 1 1997 for safety The essential requirements ERs for product safety have been in effect since 1973 This book is based on three primary directives as amended by 93 68 EEC adding the CE marking e Low Voltage Directive LVD 73 23 EEC product input 50 1 000VAC or 75 1 500VDC e Machinery Directive 89 392 EEC includes mechanical and electrical safety Electromagnetic Compatibility EMC Directive 89 336 EEC LVD prod ucts and machinery 2 CE MARKING HANDBOOK After working with numerous companies in the field of European product safety and EMC compliance I believe that confusion still surrounds the CE marking in countries outside of the European Union especially in the United States The value of the CE marking for selling products has been overstated and the associated risks of nonconformity have been in general not well understood The actual pur pose of the CE marking is to allow products to be placed on the market and ensure the free movement of goods With the exception of some high risk products most products can be self assessed by the manufacturer to meet the ERs of the directives The CE marking and a document called a declaration of conformity imply confor mity with all relevant directives Final acceptance of the product however is driven by the market consumers In addition to the CE marking affixed to a product customers may demand a European third party not
253. ud PE on its own terminal preferred 12 Power Disconnect A hand operated power disconnect device shall disconnect the whole equipment from main input supply power There are several possibilities A user accessible disconnect switch located on the front of the product is preferred but not the only option Some of the power disconnect methods are 1 Disconnect switch ON OFF 2 Circuit breaker 3 Plug on power supply cord portable or small equipment lt 16 A user warning required 4 Service disconnect switch lockable for machines 5 Building disconnect device for permanently connected equipment warn ing required Mains disconnect devices must meet these requirements 1 3 mm minimum contact separation 2 connected close to incoming supply and 3 clearly marked with the symbols for ON and O for OFF A double pole disconnect device switch breaker other should be used and should disconnect both poles simultaneously In some products a single pole device may be allowed to disconnect only the phase conductor when the neutral can be ver ified but this is often not possible since plugs are reversible in many EU countries such as in Germany Parts that remain live after the disconnect device is opened OFF shall be guarded against accidental contact by service personnel and a warn ing label is necessary adjacent to the hazard areas Emergency stop E stop switches common to machinery and some products
254. udes bibliographical references and index ISBN 0 7506 9819 5 hardcover alk paper 1 Standardization Law and legislation European Union countries 2 Product safety Law and legislation European Union countries 3 Machinery Safety regulations European Union countries 4 Standardization European Union countries Marks I Title II Series KJE6554 L64 1998 341 7 54 de21 98 21463 CIP British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library The publisher offers special discounts on bulk orders of this book For information please contact Manager of Special Sales Butterworth Heinemann 225 Wildwood Avenue Woburn MA 01801 2041 Tel 781 904 2500 Fax 781 904 2620 For information on all Butterworth Heinemann publications available contact our World Wide Web home page at http www bh com 100987654321 Printed in the United States of America For Tricia Traci Tom and Carol This Page Intentionally Left Blank Contents Chapter 1 Chapter 2 Chapter 3 Chapter 4 Preface xi Europe s Approach to Total Harmonization 1 The European Union and the CE Symbol l Definitions and Considerations 3 History The German Model 6 The New Approach 1985 8 Standards versus Directives for Conformity 11 Directives and Procedures 15 Directives The European Laws 15 General Product Safety Protection and Safeguards 18 Product Liability
255. urope 1 Manufacturer s assessment of the directive on the basis of conformity with European harmonized standards and or the ERs 2 EC body assessment based on European harmonized standards or other criteria that is when no har monized or equivalent national standard exists or in the case of innovation another specification deemed acceptable by EC body 3 EC body assessment and approval of technical file based on European harmonized standards and or other criteria i e Annex IV listed machinery 89 392 EEC or for EMC where standards are only applied in part 4 A technical file declaration of conformity and CE marking is required under all three procedures to Approved Type and Affixes CE Marking and Affixes CE Marking Figure 2 6 Conformity Assessment Procedures Voluntary certification Oftentimes manufacturers have products assessed by a European body notified or competent for a mark and certification for marketing purposes and as a defense of due diligence in the event of a challenge The intervention of notified body certification route provides confirmation of accuracy of the testing and documentation test reports etc Directives and Procedures 31 Mandatory certification Most products and machines do not require manda tory certification But in such cases as with some high risk machinery or when harmonized standards do not exist or are not applied in full a type examination
256. use red mushroom buttons on a yellow background which is universally recognized by operators and service personnel E stop devices have special requirements such as positive opening manual reset fail safe and should be type approved as E stops see Emergency Stop Switches section 13 Circuit and Thermal Protection Circuit protection devices such as fuses breakers or fault interrupters may be required in case of excessive current draws as a result of a short circuit overcur rent or earth fault Several options exist with circuit breakers preferred over fuses In some of the newer devices several functions are combined into one thereby reducing the total number of components An example of this is a combined power switch circuit breaker The switch breaker is used as a switch and breaker and senses each line and opens all lines except the grounded line simultaneously when a fault current is present Also the switch breaker looks and functions as a standard power ON OFF rocker switch In some standards simultaneous interruption of the phase and neutral is required thereby precluding the use of fuses 108 CE MARKING HANDBOOK Fuses must be properly rated for performance in respect to voltage current characteristics and breaking capacity and they must comply with the European standards Using fuses and fuseholders that are European approved ensures confor mity with the standards A time delay fuse type T may be used to avoid nui
257. veguide waveguide waveguides aerials directional coupler dipole parabolic aerial Terminals plugs sockets Connecting plug and socket clip test jack terminal board soldering terminal strip link cable sealing end and joint Electrically operated mechani Brake clutch pneumatic valve cal devices Terminations hybrid transform Cable balancing network compandor crystal filter ers filters equalizers limiters network In the General Index of IEC 817 1 Graphical Symbols for Diagrams Part 1 General Information General Index Cross reference Table 1985 the commonly used letter codes are given for items with standardized graphical symbols If more than one designation is possible because an item can be described by more than one name the more specific designation should be used FIGURE 6 10 Letter Codes for Item Designations Design Guide for Safety Conformity 127 For complex items or installations a block format is utilized such as K3M for relay K3 used for monitoring function or Q2Q1 for circuit breaker Q2 with main contact assembly Q1 The following sequence is preferred 3A 3B 3C T4O E 9 If no confusion can arise the intermediate prefix sign s may be omitted and in many cases a simplified marking block 3 is sufficient Examples of simplified markings are K3 for contactor K3 M4 for motor M4 Q6 for circuit breaker Q6 and K5M for relay K5 with a main function The following combination
258. ws of safety engineers on the other continent 6 These philosophical differences affect the testing results even when the same standards are applied The requirements contained in the European standards and the level of testing by the European bodies are recognized as stricter especially in Germany than their U S counterparts It is generally acknowledged that products meeting the European standards exceed U S standards and a product that only meets the U S standards almost certainly does not comply with the EU requirements This is generally true in most areas of product and component safety machine safety and EMC In regard to safety there are numerous technical differences between the U S and EU standards Safety guidelines under conflict include components construction spacings guarding fault and ground tests labeling manuals documentation and warnings In regards to EMC the test configuration and limits vary between the United States and European Union Most notably Europe requires additional immunity tests and more product categories covered Contrast between the EU and U S safety views are most notable but not lim ited to the followings areas Shock versus fire e Construction versus testing Office industrial environment clean dust and water versus outside inside rain no rain Production hi pot and ground testing versus hi pot or no tests and e Liability approved versus listed
259. y 81 Materials flammability of 111 12 Mechanical hazards 108 10 Metric system 75 Mindset safety 75 76 Minimum acceptable criterion 46 49 Minimum criterion 42 Model and type relationship 113 Modules 27 31 defined 27 Motors 118 19 MRA mutual recognition agreements 55 Mutual recognition 54 N National authorities defined 5 6 National enforcement authorities 42 National networks 55 Network of national networks 55 New Approach 1985 8 11 152 CE MARKING HANDBOOK New Approach Directives 35 Notification defined 55 Notified bodies and certification 53 63 approval marks 56 57 certification 56 57 defense of due diligence 57 63 testing 56 57 defined 6 and third parties 53 56 Notified competent bodies 3 defined 10 NRTL Nationally Recognized Test Laboratories 71 73 0 Oil tests flaming 71 OJEC Official Journal of the European Communities 2 4 6 11 12 33 42 55 68 Operator access areas 87 120 Operator safety 116 Operators defined 86 87 P Parties third 53 56 Parts basic 124 hazardous moving 109 secured 109 Parts list critical component 95 98 PE protective earth 105 120 Personnel service 87 116 Plug and socket types in Europe 103 4 Power consumption 99 cords 104 disconnect 107 Prequalified safety sensitive components 92 Presumption of conformity 8 11 41 46 67 defined 4 Principles component 85 construction 85 Procedures confor
260. y applying standards produces a presumption of conformity v A presumption of conformity is conferred by the use of harmo nized standards Products will not benefit from a presumption of confor mity when harmonized standards are not properly applied European standards norms are usually based on IEC standards For example EMC standard EN 61000 4 2 Immunity to Electrostatic Discharge is based on IEC 1000 4 2 and product safety standard EN 60335 Safety of Household Appliances is based on IEC 335 All European standards ENs go through rigorous review by any and all interested parties National authorities whose primary responsibility is public safety participate in the review process National enforcement authorities are obliged to recognize that products in conformity with harmonized standards EN listed in OJEC and transposed into national standards are presumed to conform to the ERs of the directives When a product becomes suspect the national enforcement authority will typi cally use the EN or equivalent national standards usually with the help of a notified body to evaluate the product s conformity or lack thereof Taking any route other than the harmonized standards approach may work against those who do not con form with the recognized standards since compliance with these standards is uni versally recognized and expected by the enforcement authorities notified bodies and customers Meeting the rul

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