Dynamic Frequency Selection (DFS)
Contents
1. gs HERMON LABORATORIES EMC amp Product Safety in Medical Devices Based on 3 Edition of IEC60601 1 Presented by Michael Brun Product Safety Group Manager amp Customer Solutions Specialist brun hermonlabs com Product Safety International Approvals 9 30 10 45 Overview of standard changes in IEC60601 family e State of the art in safety for Medical Devices e Review of HAZARD RISK NORMAL CONDITION and SINGLE FAULT CONDITION concepts and their impact on compliance 11 00 12 15 Zoom in on EMC requirements e Test mode and essential performance e Documentation requirements 12 30 13 15 Lunch 13 30 14 45 Zoom in on other critical changes Home Healthcare Changes in Technical Requirements 15 00 16 00 Review of requirements for International market access e International market access on example of Japan 16 00 16 30 Questions and Answers HERMON LABORATORIES IEC 60601 X XX Standards structure Collateral standards IEC 60601 1 XX eU or EMC 60601 1 2 Systems 60601 1 1 1 IEC 60601 2 XX ef IEC 60601 2 XX _ 60601 2 XX Background The latest version of IEC 60601 1 its 3rd Edition Medical electrical equipment Part 1 General requirements for basic safety and essential performance was published in 2005 National standards for 60601 1 374 Edition were published Europe USA and Canada Alignment of exist2. CB rules for components acceptance define 4 potential situations for component requirements There is an existing IEC standard for the component e There is no standard but there is a regional or national standard for the component No component requirements exists The end product standard contains component requirements http www iecee org Operational documents iecee documents od cb2039 ed 1 0 pdf HERMON LABORATORIES Component selection Introduction of concept component approval can create a gap between your expectations for coverage of component assessment and actual testing performed The same consideration is inherent to UL s Recognized Component Conditions of Acceptability CoA Components covered under UL Component Recognition Mark program are considered incomplete and are intended to be installed into another device system or end product New tech published our article on component selection in MAINS http new techonline com nt mag 2010 05 96d7969196d7969896d7969996d7969796d7969596d796aa 47 97 47 9 amp 47 9 amp 47 9 7 99 7 47 91 7 9 7 95 7 6 amp 7 8 HERMON LABORATORIES Component approval considerations Plug and play approach to using components in your end use product will most likely not work Make sure to understand limitations of your components and prepare to cover them in end use product investigation Certification le
3. NFPA99 NFPA99 definition of Wet Location includes all operating rooms The current practice allows hospital to conduct risk assessment and for those operation rooms that are not wet they do not have to use or isolated power Report on Comments A2009 Copyright NFPA 4 3 2 2 8 3 Operating Rooms Operating rooms shall be considered to be a wet procedure location unless a risk assessment conducted by the health care governing body determines otherwise Add a new annex item A4 3 2 2 8 3 to read In conducting a risk assessment the health care governing body should consult with all relevant parties including but not limited to clinicians biomedical engineering staff and facilities safety engineering staff HERMON LABORATORIES NFPA99 Discussion minutes NFPA 99 99 94 Log 75 HEA ELS Final Action Reject 3 3 185 Wet Locations and A 3 3 185 Submitter Kim Jahn Manning Regional Healthcare Center Comment on Proposal No 99 68 Recommendation Delete text to read as follows 3 3 185 Wet Locations The area 1n a patient care area where a procedure 1 1s performed that is normally subject to wet conditions tmehrding pem rooms while patients are present including standing fluids on u floor or drenching of the work area either of which condition 15 intimate to the patient or staff 3 3 185 Wet Locations Routine housekeeping procedures and incidental spillage c do not define a wet location hc arr dido ar
4. HERMON LABORATORIES 89 Massage Chair Category A Electrical Motor Operated Appliance Electric Massager HERMON LABORATORIES 90 15 your productin questionin the DENAN Law scope Is your product category B HERMON LABORATORIES DENAN Flowchart B Overseas Mfr Japanese importer for Category products ity assessment Mandatory by RCAB Overseas nations Mfr E e j i a Application mines prr Factory Ma eee pro nm t Clause 1 or DERE Site facility check Business Safety RFI relation importer Obligation of E Issue of CoC Japanese Importer As Notifying Supplier Need to fulfill the obligation as i ey m T Business ubmittal of CoC Notifying Supplier Authorized Valid Copy relation HERMON LABORATORIES DENAN Flowchart D Overseas Mfr Japanese importer for Category B products Obligation to conform to Technical requirements Business relation Overseas Mfr can apply to 3rd party 3rd party en ere testing body for compliance testing testing Japanese Overseas Mfr not mandatory voluntaliy JP e who produces MProduct Test according to Technical Requirement Importer CategoryB Selection cjause
5. 3 Application for product approval via DMAH or directly a Class Il to RCB b Class Ill IV to PMDA RCB PMDA reviews the product application documents and checks the QMS GMP compliance on site Audit or Document Review of manufacturing facilities n HERMON LABORATORIES 110 Supplemental explanation Japanese regulations There are a number of products applicable to DENAN and Pharmaceutical Affairs Law Examples electric inhalators heater or motor operated household heating therapeutic appliances electric massagers motor operated electric bubble generators for bathtubs motor operated magnetic therapeutic apparatus household therapeutic ray apparatuses household low frequency therapeutic apparatuses etc Transformers or DC power supply units which are used only for medical equipment and which are in the range specified by DENAN are in the scope of DENAN but the Pharmaceutical Affairs Law does not apply Detachable power cords are also treated in the same manner Products subject to DENAN and with telecom or radio function are also subject to the Telecommunication Business Law or Radio Law in addition to DENAN Examples receivers with modem function for telecommunication and or radio communication function such as Bluetooth m HERMON LABORATORIES 111 Thank You
6. scope of 3 Edition The scope of IEC 60601 1 was significantly modified and expanded by deleting the phrase under medical supervision from the definition of medical electrical equipment and adding or compensation or alleviation of disease injury or disability A collateral standard IEC 60601 1 XX becomes a normative part of the general standard on the date of its publication H HERMON LABORATORIES Home Healthcare IEC 60601 1 11 2010 is the newest Collateral Standard to the 3rd Edition Published in April as IEC and already a MUST for MDD Title Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Good presentation by Dave Osborn Philips Healthcare Sector Standards and Regulations Secretary JWG6 Home Healthcare http www fda gov downloads MedicalDevices NewsEvents WorkshopsConferences UCM214274 pdf in d HERMON LABORATORIES Home Healthcare Environment Any environment that is NOT a professional healthcare facility where OPERATORS with medical training are continually available NO PROTECTIVE EARTH connection only floating type applied parts permitted unless the equipment is permanently installed by an electrician Equipment intended for the home healthcare environment
7. 60601 1 37 Edition Why to do it now Technical reasons Product introduction is only expected in 2012 Product does not comply with 2 Edition Particular or collateral standards exist only for 3 Edition e g Home Healthcare products Logistics General tendency for complicating existing requirements and adding new ones t may be easier now to get Certificate to 37 Edition than in 1 year from now Product requires major modification in 2 years from now It may be more cost effective to make file update Y H HERMON LABORATORIES Re Defining term safety for MD Certification agencies traditionally excluded high risk specialized equipment from scope of safety standards Good example are products for use in military or aircraft applications On other hand for alarm system US and European standards have included performance requirements as part of safety for years Manufacturers cannot get NRTL Listing without compliance with functional aspects In Europe harmonized functional standards exist They are not part of CE Mark Directive but insurances in Europe require compliance 3 Edition recycle term safety to make sure regulatory practice also cover MD critical performance aspects n H HERMON LABORATORIES Basic Safety 2 d Edition Regulatory gt Safety gt Quality gt Functionality 3 d Edition Basic Safety and Essential Performance BASIC SAFE
8. EN UL CSA 60950 1 274 Edition HERMON LABORATORIES 11 3 Fire enclosures IEC 60601 1 274 Edition has no requirements UL 60601 1 has flammability requirements for parts of enclosure V 2 for transportable equipment and 0 for fixed equipment In the 3rd Edition the requirements are Internal parts FV 1 for wire FV 2 for connectors printed circuit boards insulation Enclosure FV 2 for transportable amp FV 1 for fixed equipment Bottom of fire enclosure rules are aligned with IEC 60950 1 n m HERMON LABORATORIES 4 8 Components All components including wiring the failure of which could result in a hazard shall be used in accordance with their specified ratings unless a specific exception is made in the standard or through the RISK MANAGEMENT PROCESS As the end use equipment manufacturer you become responsible for ALL safety aspects of complete equipment and its installation even those of incorporated certified components H HERMON LABORATORIES Component approval The reliability of components that are used as means of protection shall be assessed for the conditions of use in the product They shall comply with one of the following e applicable safety requirements of a relevant IEC or ISO standard e where there is no relevant IEC or ISO standard the requirements of this standard have to be applied H HERMON LABORATORIES Component selection for CB approval
9. ISM bands power of transmitter bands d 1 F2 100 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 KHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Part Ill 13 30 14 45 Zoom in on critical changes Home Healthcare Changes in Technical Requirements Component selection for target market How to work with ISO 14971 n H HERMON LABORATORIES Changes
10. SIGNALS as specified in this collateral standard If deemed necessary by RISK ASSESSMENT regarding the environment in which the ALARM SYSTEM is intended to be used additional ALARM SIGNALS shall be generated These additional ALARM SIGNALS may be auditory verbal vibratory or produced by other means Please note the requirements of IEC 60601 1 8 standard relevant also to sound messages to patient sound level bandwidth and the like HERMON LABORATORIES Clinical Trials MDD specifically states that for devices intended for the clinical investigations manufacturer should provide a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that with regard to these aspects every precaution has been taken to protect the health and safety of the patient Common interpretation is that the regulatory requirements should be checked in full meaning compliance with EN60601 1 with all collateral standards In practice we have numerous cases when partial testing was accepted HERMON LABORATORIES Finding right balance Compliance with a standard offers a very good claim that the product was indeed safe but as the British Standards Institute states in the preamble to all its type test standards compliance with a British Standard does not of itself confer immunity from legal obligations 1 Use a Good Practice GMP GLP GCP and t
11. strengths should be less than F4 V m Replace ME EQUIPMENT or ME SYSTEM with the MODEL OR TYPE REFERENCE of the ME EQUIPMENT Or ME SYSTEM in six places in Table 4 and four places in Table 6 In Table 4 enter in column 3 Enter in column 3 and in table footnote b Calculate 3 5 E T E and 3 5 F Round to two significant digits Substitute results for corresponding expressions in Table 4 and Table 6 Calculate each entry in Table 6 using the equation in the corresponding column the output power in column 1 as applicable rounding to two significant digits 33507 Recommended separation distances guide Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT ME SYSTEM The ME EQUIPMENT ME SYSTEM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Ihe customer or the user of the ME EQUIPMENT ME SYSTEM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ME EQUIPMENT ME SYSTEM as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum output outside ISM in
12. 1 or Clause 2 Safety RFI LE LLLI gt product Compliance check by Mfr by themselves mProduct Test according Technical Requirement Clause 1 or Clause 2 Safety RFI Obligation of Japanese Importer T A5 Notifying Selfconfirmation mObligation to check conformity with technical requirements 5 Obligation to make and keep Need to fulfill the Submittal of the Tepe obligation as eee unc Y Notifying Supplier Obligation for marking Motifying Supplier s name HERMON LABORATORIES Electrical Appliance and Material Safety Law DENAN Category B product Safety related RFI beds if required Technical requirement Technical requirement Ordinance Clause 1 Ordinance Clause 1 Selection Technical requirement Technical requirement Ordinance Clause 2 Ordinance Clause 2 of L HERMON LABORATORIES _ Applicable Technical Requirements Standards Products specified by DENAN Law should be tested in accordance with the technical requirements standards specified by MITI Ordinance Clause 1 or 2 Selection Possible Chose one MITI Ordinance for Technical requirements MITI Ordinance for Technical requirements MITI Ordinance Clause 2 Technical requirements Technical requirements Appendix 1 8 J IEC standards Remarks Remarks N
13. BORATORIES Immunity test mode selection The main concern Maximum gain sensitivity under the greatest activity The highest receiving gain Y The highest data rate All modules exersised frequently Y Maximum cables configuration Y The minimum sufficient receive power minimum signal to noise specification Equipment provided for the test shall be a representative of production model including the final o layouts SW may be modified to allow frequent n monitoring of the EUT performance HERMON LABORATORIES ESSENTIAL PERFORMANCE IEC 60601 1 2005 Section 4 3 The MANUFACTURER Shall identify which functions of the ME EQUIPMENT and ME SYSTEMS are ESSENTIAL PERFORMANCE Where this standard specifies that ESSENTIAL PERFORMANCE IS to be maintained following a particular test these functions shall be used and compliance shall be checked by inspection and if necessary by functional test Where requirements of this standard refer to ESSENTIAL PERFORMANCE that ESSENTIAL PERFORMANCE is determined by the MANUFACTURER in accordance with the MANUFACTURER S policy for RISK acceptability Compliance is checked by inspection of the RISK MANAGEMENT FILE I L HERMON LABORATORIES Section 5 Identification marking documents Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts section 5 1 5 1 1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts that incl
14. IPMENT SYSTEM should assure that it is used in such an environment Emissions test RF emissions CISPR 11 RF emissions CISPR 11 RF emissions Class A or B CISPR 11 Harmonic emissions IEC 61000 3 2 Class A B C D or Not applicable Voltage fluctuations flicker emissions 61000 3 3 Complies or Not applicable See 5 2 2 1 c and Figure 1 See 5 2 2 1 c and Figure 1 See 5 2 2 1 c and Figure 1 RF emissions Complies CISPR 14 1 RF emissions Complies CISPR 15 Compliance Electromagnetic environment guidance The EQUIPMENT Or SYSTEM uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The ME EQUIPMENT ME SYSTEM must emit electro magnetic energy in order to perform its intended function Nearby electronic equipment may be affected ME EQUIPMENT Or ME SYSTEM is suitable for use in all establishments including domestic establish ments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes The ME EQUIPMENT ME SYSTEM is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purp
15. Not applicable in row 8 with Not applicable Merge cells in column 3 of rows 6 7 and 8 PROFESSIONAL ME EQUIPMENT or ME SYSTEM intended and justified for domestic or PUBLIC MAINS use Yes B Move text from column 3 Move text from column 3 Move text from column 3 of row 9 into merged of row 10 into merged of row 11 into merged cell Yes Add text specified by 5 2 2 3 b Allowance in 6 1 1 1 d used Specified for use in a shielded location Delete rows 9 10 and 11 Delete row numbers Row numbers refer to those in Table 1 before modifications are made Including TYPE A PROFESSIONAL ME EQUIPMENT and ME SYSTEMS IEC 33107 Guidance 5 declaration electromagnetic IMMUNITY Guidance and manufacturer s declaration electromagnetic immunity The ME EQUIPMENT or ME SYSTEM is intended for use in the electromagnetic environment specified below The customer or the user of the ME EQUIPMENT or ME SYSTEM should assure that it is used in such an environment IEC 60601 test level Compliance level IMMUNITY test Electrostatic discharge ESD IEC 61000 4 2 t 6 kV contact t 8 kV air Electrical fast transient burst IEC 61000 4 4 t 2 kV for power supply lines t 1 kV for input output lines surge IEC 61000 4 5 1 kV line s to line s t 2 kV line s to earth lt 5 UF gt 95 dip in 17 f
16. Pharmaceutical Affairs Law PAL NE Pharmaceutical m Topic Affal S 6 Law law n HERMON LABORATORIES Pharmaceutical Affairs Law PAL Yakujiho http www mhlw go jp Article 1 This law is intended to provide regulations required to ensure the quality efficacy and safety of drugs quasi drugs cosmetics and medical devices and to improve the public health and hygiene through necessary measures taken to promote the research and development of drugs and medical devices which are of particular importance to the medical practice 99 HERMON LABORATORIES New System of Medical Devices Classification General Medical Devices Class I extremely low risk Potential risk is almost insignificant in case of malfunction or side effect Examples scalpel X Ray film Designated Controlled Medical Devices Class ll low risk Having potential risk in case of malfunction or side effect Examples electronic sphygmomanometers gastric catheters Specially Controlled Medical Devices Class lll IV middle high risk Potential risk is significant in case of malfunction or side effect Examples dialyzer pacemaker stent H 100 HERMON LABORATORIES Product Certification Classification by PAL General Designated Specially Controlled MD Controlled MD MD Product Certification Product Approval by MHLW Application to PMDA PMDA Pharmaceuticals an
17. T shall not have surface temperatures exceeding 41 C 2 9 12 During the test Thermal cut outs shall not be de activated and shall not operate EP is compliance with operational test requirements of IEC60601 1 274 Edition zz IEC60601 collateral and particular standards H HERMON LABORATORIES for 219 Edition IEC60601 1 2 2001 274 Edition mandatory since 2004 already has term ESSENTIAL PERFORMANCE taken from draft of IEC60601 1 2005 It allows a risk analysis to be used to determine the EP and safety of MD that must be examined during IMMUNIT Y testing and whether testing according to this standard is required for non medical electrical equipment that is combined with MEDICAL ELECTRICAL EQUIPMENT to form a SYSTEM H HERMON LABORATORIES for products with alarm conditions If MD needs to notify the OPERATOR that a HAZARDOUS SITUATION can exist then MD shall include an ALARM SYSTEM complying with this collateral standard for that purpose The definition of ALARM CONDITION is state of the ALARM SYSTEM when it has determined that a potential or actual HAZARD exists If you determined that such state exists then EN IEC 60601 1 8 is applicable HERMON LABORATORIES Alarm Signals and if applicable you need to generate visual signal as specified below 6 3 Generation of ALARM SIGNALS 6 3 1 General Each ALARM CONDITION shall cause the generation of visual ALARM
18. TY is freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION n HERMON LABORATORIES ESSENTIAL PERFORMANCE ESSENTIAL PERFORMANCE EP is defined as performance necessary to achieve freedom from unacceptable RISK Medical Devices MD are integral part of modern medical care MD functionality and reliability also associated with quality of care The quality of MD has been always part of regulation Compliance with ISO 13485 is part of regulatory requirements for MD H HERMON LABORATORIES HAZARD HARM RISK what ts the difference HAZARD is any source of potential damage harm or adverse health effects on something or someone under certain conditions at work HAZARD can cause HARM to individuals as health effects or to organizations as property or equipment losses RISK is combination of the probability of occurrence of HARM and the severity of that HARM Ht HERMON LABORATORIES Traditional SAFETY Concepts 2 d Edition Regulatory gt Safety gt Quality gt Functionality SAFETY standard is set of requirements for construction and performance of Medical Device MD to ensure a sufficient degree of protection against SAFETY HAZARDS under NORMAL CONDITION and SINGLE FAULT CONDITION But IEC60601 1 2 2001 2 Edition EMC already has term EP taken from draft of IEC60601 1 2005 It all
19. afety es referred to in Sections 1 2 d3m E not be e adversely affected when the device is subjected to the str hich can occur during normal ct Il REQUIREMENTS 11 Protection against 11 1 General Devices shal persons to radiation shall b application of appropriate sp 11 2 Intended radiation 11 2 1 Where devices are design it hazardous levels of radiation for a specific medical purpose the benefit of which is considered to is T 2 the emissions Such devices shall b variable parameters 11 2 2 Where devices are intended to emit potentially hazardous visible and or invisible radiation they must be fitted where practicable with visual displays and or audible warnings of such emissions 11 3 Unintended radiation Devices shall be designed and manufactured in such a way that exposure of patients users and other persons to the emission of unintended stray or scattered radiation is reduced as far as possible 11 4 Instructions The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation 1 manufactured to ensure HERMON LABORATORIES IEC 60601 X XX Standards structure Particular standards 60601 2 XX IEC 60601 2 10 Amend 5 rm IEC 60601 2 XX L some particu
20. d Medical Devices Agency Independent Agency of the MHLW H LI HERMON LABORATORIES 101 Marketing Authorization Holder Resposible for distribution quality of the product and manufacturing and for vigillance system Products can be sold only to MAH er or Manufacturer License for Marketing Authorization Holders Article 12 Classification by PAL pes Class III Class IV Designated Specially Controlled Controlled MD MD Type of Marketing Authorization Holders No 1 Type License for Marketing 0 gt 0 Type Business of Medical Devices 102 HERMON LABORATORIES Li Supervising function GQP GVP supervision supervision Post marketing safety measures function Good Quality Practice GVP Good Vigilance Practice Sales office j retail manufacturing business Site QC compliant with the revised QMS GMP ISO 13485 HERMON LABORATORIES Marketing Authorization System 1 License to Marketing Business gt MAH Marketing Authorization Holder 2 License Registration for Manufacture Production License Registration 3 Device Approval MHLW Certification RCB Product Approval Certification n H HERMON LABORATORIES 104 Special Rules for Foreign Manufacturers A foreign manufacturer who intends to get product approval or product certifica
21. d hazardous situation the associated risk s shall be estimated using available information or data For each identified hazardous situation the manufacturer shall decide using the criteria defined in the risk management plan if risk reduction is required The results of these activities shall be recorded in the risk management file HERMON LABORATORIES Working with Risk Management File Manufacturer Test Lab Risk Analysis formulation amp device design Typically the tests of greatest impact are abnormal operation amp fault conditions amp essential performance tests in the Parts 2 Adjustments to Risk Analysis amp device design Residual Risk acceptable Y Risk Management File There are more than 100 times where 3 d Edition requires to determine risk acceptability in applying a particular requirement Test Laboratory shall verify compliance on a product basis and fill in the checklist in the Technical Report Form TRF in Wi HERMON LABORATORIES ISO 14971 assessment Requirement for the manufacturer of medical equipment and systems to have a formal risk management system that conforms to ISO 14971 There are two options how the requirements of ISO 14971 should be evaluated review of a manufacturer s documentation or e on site assessment of a manufacturer s risk management process A certificate for 15014971 is certainly a useful asset but it d
22. deii Substantiation MRHC has 1 surgery suite and 1 minor procedure room electrical receptacles are grounded and we have not had any electrically related incidents in either location since I began employment here in 1985 I believe the proposed changes to the code will only increase my costs of operation in a time when everyone in this country 1s complaming about the high cost of scu Mist guis de this 15 in a opinion T p e dida were nin oL byA ASHE and I I with them Committee Meeting Action Reject Committee Statement See the Committee Action and Statement on Comment 99 89 Log 64 Number Eligible to Vote 23 Ballot Results Affirmative 21 HERMON LABORATORIES Manufacturer responsibilities Member States shall take all necessary steps to ensure that devices may be placed on the market and or put into service only if they comply with the requirements laid down in this Directive A product is placed on the market when it is made available for the first time This is considered to take place when a product is transferred from the stage of manufacture with the intention of distribution or use on the Community market Putting into service means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose Both terms refer to each individual product not to a type
23. ences Always has been and still remains a problem 2nd Ed Particular standards be synchronized with withdrawn collateral standard like IEC60601 2 24 1996 still in force is based on 60601 1 2 1993 3 d Ed following referenced documents are indispensable for the application of this document For dated references only the edition cited applies For undated references the latest edition of the referenced document including any amendments applies IEC 60950 1 2001 Information technology equipment Safety Part 1 General requirements IEC 60825 1 1993 Safety of laser products Part 1 Equipment classification requirements and user s guide with Amendment 1 1997 and Amendment 2 2001 as HERMON LABORATORIES O Zoom in on IEC 60950 1 2001 2005 1 60950 1 2 Edition is published and can be used as alternative for superseded 60950 1 1 Edition for CB Scheme 2006 1 60950 1 2 Edition is adopted as 60950 1 2006 2007 1 60950 1 2 Edition is adopted as UL CSA60950 1 2007 and EN60950 1 2006 is Listed in OJ in 2007 R amp TTE 2008 60950 1 2006 is Listed OJ in 2008 LVD 2010 On December 15 EN UL CSA 60950 1 2001 and its amendment are withdrawn IEC60950 1 15 Edition may still be used as a national standard by other countries also after 2010 But most component manufacturers will move after N America and European Markets and certify components to
24. evant skin Effects on N E Not relevant E Not relevant Tue p Genetic mutation E Not relevant E Not relevant No Risk Optical radiation Burn N A E Not relevant E Not relevant infrared visible and ultraviolet Damage to eyes and Long A Very Likely C Moderate including laser skin term exposur Effects on N A E Not relevant E Not relevant reproductive capability Genetic mutation E Not relevant E Not relevant No Risk etc systematic application of management policies PROCEDURES and practices to the rm etc RISK MANAGEMENT tasks of analyzing evaluating and controlling RISK HERMON LABORATORIES 4 2 Risk Management Process Requirement for the manufacturer of medical equipment and systems to have a formal risk management system that conforms to ISO 14971 There are more than 100 times where 3 Edition requires to determine risk acceptability in applying a particular requirement Test Laboratory shall verify compliance on a product basis and fill in the checklist in the Technical Report Form H HERMON LABORATORIES Risk Management File The manufacturer shall compile documentation on known and foreseeable hazards associated with the MD in both normal and fault conditions Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation shall be considered and the resulting hazardous situation s shall be recorded For each identifie
25. g in scope of another regulation e g therapeutic apparatus for households use microwave oven etc HERMON LABORATORIES 84 Product categories Category B products oth er electrical lance and materia p S Total 339 items E Denki Yohin Electrical Appliance and Materials Category Products specified electrical aj pliance and materials Total 115 items Category and Category B Total 454 items H L HERMON LABORATORIES 85 Electrical products in Japanese market Products controlled Products not controlled by DENAN 1 py DENAN Category A products 115 items Other electrical products which are not in scope of DENAN but may be in scope of other regulations e g Radio Law Pharmaceutical Affairs Law etc Category B products 339 items d dd HERMON LABORATORIES 86 E 5 O O gt i gt E 5 p gt HERMON LABORATORIES 87 Category Appliance DC Power Supply Uni AC Electrica Extension Cord Set O Category A Wiring Devices Multi Tap Cord Attachment Plug respective part adu IBN HERMON LABORATORIES 88 Category B Electrical Motor Operated Appliance Electric Hair Dryer
26. gistered Certification Body Applicant MAH Post Market Requirement Conformity Quality Assurance Item Conformity Manufacturing Site Manufacturer Facility Structure Criteria Mfg Control Quality Control GMP QMS Document Review Certification Application Document Certification Product evaluation based on individual conformity criteria of product On Site Doc Audit for conformity to ordinance 169 Confirm evidence related to criteria conformity as needed On Site or Doc Audit Follow up Audit After Certification Follow up Audit related to Ordinanee 169 GMP QMS Conformity once a year HERMON LABORATORIES 108 Registration of the Production Site Application e Name of the manufacturer e Address e Registration category Attachment for buildings and equipment Name amp private address of the management representative Name amp address of the applicant could be foreign manufacturer or MAH 109 Attachments Overview technical drawings of the buildings and the equipment Hesume of the management representative List of the manufactured products Manufacturing process Copies of existing licenses approval or certificates HERMON LABORATORIES 3 simple steps to access Japan 1 Appointment of the DMAHer in Japan 2 Accreditation of the production facility by PMDA
27. he like 2 Make your own Project Risk Assessment and Risk Mitigation Plan HERMON LABORATORIES Conclusions Part For some MDs compliance to 3 Edition is now the only option to obtain regulatory approval Various national regulators accept 37 Edition and have already announced withdraw date for 274 Edition For various product categories safety assessment becomes state of the art project with major time and cost implications Always review your contract with test lab to understand SOW It is not only Certificate of Compliance but also Test Report and its content HERMON LABORATORIES Part Electromagnetic compatibility requirements for Medical Devices Presented by Mr Michael Nikishin Hermon Laboratories EMC amp Radio Group Manager HERMON LABORATORIES Essential requirements under 93 42 Medical Devices Directive MDD Annex GENERAL REQUIREMENTS 1 The devices must be designed and manufactured in such a way that when used under the conditions and for the purposes intended they will not compromise the clinical condition or the safety of patients users or other persons provided that any risks which may be with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of heal fety 2 The solutions adopted by the ma he design and construction o ices must conform to s
28. ies with applicable international EMC standards both the EMISSIONS and IMMUNITY of the electrical equipment that is not ME EQUIPMENT have been determined not to adversely affect the BASIC SAFETY or ESSENTIAL PERFORMANCE the EMISSIONS of the electrical equipment that is not ME EQUIPMENT have been determined not to cause the EMISSIONS of the ME SYSTEM to exceed applicable limits Check compliance by inspection of the documents Ud HERMON LABORATORIES Separation into groups Group 1 equipment contains all equipment in the scope of this standard which is not classified as group 2 equipment Most types of ME EQUIPMENT and ME SYSTEMS generate or use RF energy only for their internal functioning and therefore belong to group 1 Group 2 equipment contains equipment in which RF energy is intentionally generated and applied in the form of electromagnetic radiation inductive and or capacitive coupling to patients Only a few EQUIPMENT apply RF energy to PATIENTS and are therefore members of group 2 HERMON LABORATORIES Group 1 equipment Group 1 equipment contains all equipment in the scope of this standard which is not classified as group 2 equipment Most types of ME EQUIPMENT and ME SYSTEMS generate or use RF energy only for their internal functioning and therefore belong to group 1 Electro and magneto cardiography EQUIPMENT Electro and magneto encephalography EQUIPMENT Electro and
29. ing collateral standards IEC 60601 1 XX and most of particular standards IEC 60601 2 XX to 3 Edition is completed All new collateral and particular 60601 X XX standards are aligned to 3 Edition NOTE The main standard shall be used together with the collaterals and particulars aligned with this main standard It may be a position of specific regulatory body to accept 274 Edition of main standard with particular standard aligned with 3 4 Edition as HERMON LABORATORIES EN 60601 1 status information Collateral Title Comment DEM ELECTRICAL SYSTEMS Recte REQUIREMENTS AND TESTS GENERAL REQUIREMENTS FOR m RADIATION PROTECTION IN DIAGNOSTIC EQUIPMENT MEDICAL SYSTEMS USABILITY 00000000 GENERAL a TESTS GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS Requirements for environmentally not in conscious design Requirements for the development of now physiologic closed loop controllers rome heath HERMON LABORATORIES IEC 60601 1 3 Edition Why NOT to do it now Technical Do not comply with 374 Edition Particular standard exist only for 2 Edition e g Part 2 24 Particular requirements for the safety of infusion pumps and controllers 60601 2 24 19968 Logistics Many markets still do not accept 3 Edition most cases of particular standards your product will become clinical tria
30. l for test methods It has taken time for the industry and regulators to understand the new concepts Major issue can arise which will take much time to get resolved n HERMON LABORATORIES 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 all x LU NT TRES UEM Pm nc ee MESS OC mE m A M E Signal generator 20 mains frequency tn n Switches including or provoking shortcut of unbalance circu of D A w PO gt 5 capacitance to ground The inner shield used to reduce the pickup of unwanted to ground Since ihe capacitan ciance and tha commen mode vo at the common mode point with a source imped Figure 114 Test circuit for common mode rejection yum YY p ECG Lead Wires ANSI AAMI EC13 2002 Annex C Need for this annex Many questions and vigorous discussions in and outside of committee meetings have arisen over the proper design construction and use of the test circuit prescribed in this standard for CMR and channel noise testing It is the intent of this annex to resolve those questions and discussions and in 50 doing foster greater testing consistency HERMON LABORATORIES IEC
31. lar standards provide additional set d up requirements and or test limits for EMC ELECTROMAGNETIC COMPATIBILITY Section 4 1 1 ME EQUIPMENT and ME SYSTEMS shall not emit ELECTROMAGNETIC DISTURBANCES that could affect radio services other equipment or the ESSEN TIAL PERFORMANCE of other ME EQUIPMENT and ME SYSTEMS ME EQUIPMENT and ME SYSTEMS shall have adequate IMMUNITY to be able to provide its BASIC SAFETY and ESSENTIAL PERFORMANCE in the presence of ELECTROMAGNETIC DISTURBANCES Consider compliance to exist if the requirements of this collateral standard are met rm Li HERMON LABORATORIES Reference standard Radiated emissions CISPR 11 Conducted SISSE CISPR 11 AC power Class A Class B 6100032 6100032 Voltage fluctuations and flickers IEC 61000 3 3 IEC 61000 3 3 Test level Class A Class B Class A Class B Class A Class B HERMON LABORATORIES Immunity test levels Contact 2 4 6 kV Air 2 4 8 kV AM 80 1 kHzor 10 V m AM 80 2 Hz Life support Reference standard Test Procedure RI to RF fields IEC 61000 4 3 EFT IEC 61000 4 4 Other lines Differential 0 Q 20 0 5 1 0 IEC 61000 4 5 AC power Common 10 O 12 Q 0 5 1 0 2 0 DC power 0 15 80 MHz Cl to RF fields IEC 61000 4 6 Other lines Magnetic fields 61000 4 8 Enclosure 50 60 Hz 3 10 ms 100 ms 0 15 80 MHz 5 50 ns AM 80 1 kHz 3or 10 Vims AM 80 2 H
32. le transducers and other ACCESSORIES A warning that the use of ACCESSORIES transducers and cables other than those specified may adversely effect EMC Guidance and MANUFACTURER S declaration ELECTROMAGNETIC EMISSIONS A warning that the ME EQUIPMENT or ME SYSTEM should not be used adjacent to or stacked with other equipment A justification for each COMPLIANCE LEVEL that is lower than the IEC 60601 TEST LEVEL Guidance and MANUFACTURER S declaration electromagnetic IMMUNIT Y The performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL a PERFORMANCE Accompanying documents Instructions for use Technical description Guidance and manufacturer declaration Electromagnetic emissions life supporting and not life supporting equipment Guidance and manufacturer declaration Electromagnetic immunity life supporting and not life supporting equipment Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM life supporting and not life supporting equipment m HERMON LABORATORIES Guidance and manufacturer s declaration electromagnetic EMISSIONS Row OO Guidance and manufacturer s declaration electromagnetic emissions The ME EQUIPMENT Or ME SYSTEM is intended for use in the electromagnetic environment specified below The customer or the user of the ME EQU
33. magneto myography EQUIPMENT EQUIPMENT intended to deliver energy to the PATIENT but in a form that is other than RF electromagnetic HERMON LABORATORIES Group 2 equipment Group 2 equipment group 2 contains equipment in which RF energy is intentionally generated and applied in the form of electromagnetic radiation inductive and or capacitive coupling to patients Only a few EQUIPMENT apply RF energy to PATIENTS and are therefore members of group 2 MRI Therapy EQUIPMENT Diathermy EQUIPMENT short wave ultra short wave microwave therapy EQUIPMENT Hyperthermy EQUIPMENT High frequency surgical EQUIPMENT HERMON LABORATORIES Class installation environment Installation environment Standard Office Light industry Home Domestic __ m a Generic standards B Medical standard Class A rest of standards EN55022 EN55011 EN300 386 ENe1326 Class Class Class A EN 301 489 X M H Class A HERMON LABORATORIES Emissions test mode selection The main concern Maximum power under the greatest activity The highest transmission power The highest data rate Y The highest power consumption Y Maximum cables configuration Y Maximum load conditions Equipment provided for the test shall be a representative of production model including the final layouts and final SW revisions n O HERMON LA
34. must be Class B with respect to emissions The usability evaluation is required ENCLOSURES must be at least IP21 light rain proof TRANSIT OPERABLE HANDHELD and BODY WORN equipment must be at least IP22 n HERMON LABORATORIES Do not seal battery compartments International Approvals for Home Healthcare Before IEC 60601 1 11 manufacturers of healthcare equipment intended for use in homes have been required to comply with Europe EN60335 1 with particular standards N America UL60601 1 UL1431 ROW IEC60335 1 or IEC 60601 1 After IEC 60601 1 11 which covers most home healthcare equipment some devices may still be subject to the requirements of other standards For example UL1431 Personal Hygiene and Health Care Appliances covers household electric products for hygiene or other healthcare applications rated at 250 V or less Products covered under this standard include hydromassage units nebulizers breast pumps toothbrushes and contact lens disinfectors Europe EN60601 1 Ed With 60601 1 11 America ANSI60601 1 with IEC60601 1 11 UL1431 ROW IEC60335 1 or IEC 60601 1 27 Ed HERMON LABORATORIES International Approvals scheme CB Scheme proved itself as most reputable Also governmental bodies act as NCBs in CB Scheme and as such have to accept CB test reports Example Importers to Israel of MAINS powered Home Healthcare equipment need to te
35. nt are not synchronized between various regulators and test labs TRF is published and has been in use for several years now but does not provide sufficient detail on the content of essential performance and risk analysis HERMON LABORATORIES Part IV 15 00 16 00 Review of MD requirements for International market access JAPAN Information on the following slides is quoted from presentation The Regulatory System for Importing Electrical electronic Goods to Japan by Mr Kurt K Heinz of NCB TUV Rheinland Japan presented on CB Scheme Workshop in Tel Aviv on 29 June 2010 n H HERMON LABORATORIES 1 Electrical Appliance and Material Safety Law DENAN Law gt E 2 New Pharmaceutical Affairs Law PAL H HERMON LABORATORIES 83 Electrical Appliance and Material Safety Law DENAN In the DENAN Denki Yohin is classified into two categories Category and Category Category A product Need to obtain Certificate of Conformity CoC by Registered Conformity Assessment Body RCAB Registered by Japanese Government Category B product Not necessary to get CoC but there is the obligation to conform to the Technical Requirements stipulated by the Ministerial Ordinance Self verification confirmation can be done by manufacturer NOTE There are many other products not being in scope of DENAN Law And even if subjecting to DENAN there are also products bein
36. oes not exempt the safety test lab from having to verify compliance on a product basis and filling TRF contains some of the risk management requirements but does not provide sufficient detail on the content Y H HERMON LABORATORIES Technical report IEC TR 62354 To synchronize testing procedures for medical electrical equipment based 3 4 Edition of IEC 60601 1 between various regulators and test labs second edition of IEC TR 62354 has been published in 2009 This technical report a guidance not a standard primarily covers the third edition of IEC 60601 1 but not collateral and particular standards ANSI AAMI IEC TIR62354 2009 General testing procedures for medical electrical equipment has been published a year ago March 2010 To establish uniformity between test laboratories in assessment of ISO 14971 requirements the Risk Management Task Force RMTF has been established The main task is to detail the needed elements for inspection of the risk management file as called out in IEC 60601 1 Based on this work it is anticipated that the TRF will be modified HERMON LABORATORIES Conclusions Part System approach has always been required but 374 Edition put more stress on it in form of risk management You need to understand your product environment to make proper component selection and provide expected level of safety Major aspects of essential performance and risk manageme
37. of product and whether it was manufactured as an individual unit or in series n m HERMON LABORATORIES CE Placement on the market The product placed on the market or put into service must meet the current list of harmonized standards as the standards are updated and published under the European Journal Once withdrawn the standard will be removed from the EU list of harmonized standards and will no longer provide a presumption of conformity for the purposes of CE marking H HERMON LABORATORIES Europe Product Liability Directive The product should comply with the state of the art in safety on the day it was supplied or put into service State of the art for European product liability means the state of scientific and technical knowledge at that time which includes all published standards even those not listed under a Directive Complying with the regulatory standards for medical equipment and systems does not necessarily ensure compliance with the medical safety regulations or with product liability and other safety laws http www conformity com artman publish printer feature247 shtml s n HERMON LABORATORIES EP in 2 4 Edition Although this Standard is primarily concerned with safety it contains some requirements regarding reliable operation where this is connected with safety Example 42 3 APPLIED PARTS of equipment not intended to supply heat to a PATIEN
38. or 0 5 cycle 40 17 60 dip in Uz for 5 cycles 10 Ur 30 dip in Uz for 25 cycles 5 UF gt 95 dip in Ur fords Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE is the a c mains voltage prior to application of the test level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the ME EQUIPMENT ME SYSTEM requires continued operation during power mains interruptions it is recommended that the ME EQUIPMENT or ME SYSTEM be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Replace ME EQUIPMENT or ME SYSTEM with the MODEL OR TYPE REFERENCE of the ME EQUIPMENT or ME SYSTEM in four In Table 2 column 3 enter the COMPLIANCE LEVEL or Not applicable if appropriate for each test In Table 2 replace the text in
39. oses provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such re orienting relocating the EQUIPMENT ME SYSTEM or shielding the location The ME EQUIPMENT Or ME SYSTEM is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpases The ME EQuIPMENT is not suitable for interconnection with ather equipment The ME EQUIPMENT is not suitable for interconnection with other equipment Start for CISPR 11 ME EQUIPMENT and ME SYSTEMS Replace EQUIPMENT or ME SYSTEMI with MODEL OR TYPE REFERENCE of the EQUIPMENT or ME SYSTEM Delete rows 4 12 and 13 Group 2 Delete rows 5 12 and 13 from Table 1 from Table 1 B A Replace or B Class Replace or BF IEC 61000 3 2 and 61000 3 3 compliance Complies Not applicable Replace Class A B C D or Not applicable in row 7 with the IEC 61000 3 2 class and replace Complies Not applicable in row 8 with Complies Merge cells in column 3 of rows 6 7 and 8 Replace Class B C D or Not applicable in row 7 and Complies or
40. ot only Safety requirements but Not only Safety requirements but also RFI requirements are included also RFI requirements are included Technical Requirements consist of two standard groups CategoryA products Category B products are required to be tested according to the following standards Either Clause 1 or Clause 2 Need to be in compliance with either Clause 1 or Clause 2 HERMON LABORATORIES Category product Forexample DC Power Supply Unit T Product Evaluation pe Aa Technical Requirement test equipment Clause 1 Safety amp RFI of manufacturer Need both compliances HERMON LABORATORIES Manufacturer survey by RACB Audit Registration 4 Notification of 4 starting business Request for CoC Category A gt Registered Products Legal action Conformity e if necessary I Issue m bs Assessment i lt Ministry of CoC Notifying Supplier Economy Body yng PP Notification of y starting business Trade and m BL LEE Importer P m gt Industry Registration by Request for CoC Category A EHEHEHE E _ Issue Legal action of s if necessary CoC Request for CoC Submit of CoC equivalent equivalent Request for CoC Overseas manufacturer Application category A product equivalent n HERMON LABORATORIES 97 New
41. ows a risk analysis to be used to determine the EP and safety of MEDICAL ELECTRICAL EQUIPMENT that must be examined during IMMUNITY testing n H HERMON LABORATORIES RISK MATRIX RISK is combination of the probability of occurrence of HARM and the severity of that HARM Probability Not relevant Risk can be acceptable e g green area or unacceptable red HERMON LABORATORIES Operating Conditions NORMAL CONDITION condition in which all means provided for protection against SAFETY HAZARDS are intact SINGLE FAULT CONDITION Condition in which single means for protection against a SAFETY HAZARD is defective or asingle external abnormal condition is present HERMON LABORATORIES Re defining terms for Operating Conditions Faults are divided into 3 probability categories so remote that they can be ignored e g REINFORCED INSULATION TENSILE SAFETY FACTOR of 8X COMPONENT WITH HIGH INTEGRITY CHARACTERISTICS e probable enough that they need to be considered but improbable enough that they need only be considered one at a time SINGLE FAULT so likely so unpredictable or undetectable that they are considered to be a NORMAL CONDITION and need to be considered individually and collectively WORST CASE n H HERMON LABORATORIES WORST CASE or SINGLE FAULT Until now two or more independent faults were considered so unlikely that only single fault iss
42. rected at the rotten area which contains more water molecules than the rest of the tooth 2 Water molecules in the decay are heated rapidly Pressure increases and the rotten area explodes making a popping sound Eo com gt J The laser kills any Decay 1 bacteria in the area so the tooth is sterilised ff 69 HERMON LABORATORIES Zoom in on ESSENTIAL PERFORMANCE Performance requirements for specific MD defined by manufacturer based on RISK ASSESSMENT zz In 60601 1 3 Edition it is compliance with constructional and test requirements of main standard 60601 collateral and particular standards n HERMON LABORATORIES Hisk Assessment RISK ANALYSIS is systematic use of available information to identify HAZARDS and to estimate the RISK RISK EVALUATION is a judgment on the basis of RISK ANALYSIS of whether a RISK which is acceptable has been achieved in a given context based on the current values of society RISK ANALYSIS RISK EVALUATION RISK ASSESSMENT overall PROCESS comprising a RISK ANALYSIS and a RISK EVALUATION H HERMON LABORATORIES Risk Control and Management RISK CONTROL PROCESS through which decisions are reached and protective measures are implemented for reducing RISKS to or maintaining RISKS within specified levels sequen Radiation lonising radiation Burn N A E Not relevant E Not rel
43. st sample at SIl or provide CB or TUV Certificate and Report to IEC60601 1 to get Import Permit To qualify product for exemption from SII Import Permit for limited import mostly for private use importer needs to file request with Ministry of Industry Trade and Labor and attach CB Certificate and Report n H HERMON LABORATORIES Changes in technical requirements Significant changes in technical requirements in body of the standard liberal view on isolation requirements for the Operator e IEC 60950 1 Incorporates collateral standards for System 60601 1 1 and SW 60601 1 4 e Incorporates particular standard for total patient leakage current 60601 2 49 e Compliance requirements for Non hazardous Lasers e liberal view on temperatures on Applied Parts Other changes n H HERMON LABORATORIES electrical equipment One of the most advertised technical changes 374 Edition is the relaxation of operator protection requirements which makes for significant savings on the cost of medical equipment For example if a device or its components do not touch the patient then that device or its components only need to meet the less stringent insulation and leakage requirements of IEC 60950 1 ITE What about EMC Most probably ITE device or its components do not comply with immunity requirements of MD HERMON LABORATORIES Normative refer
44. te needs Appointed Designated MAH D MAH in Japan D MAHer may be 1 Distributor 2 Third party 3 Company s subsidiary in Japan n H HERMON LABORATORIES 105 License Registration for Manufacture License for Manufacture is required for all production sites also abroad with the exception of component suppliers Inspection and registration is done by Prefecture and PMDA Pharmaceuticals and Medical Devices Agency These organizations reserve the right to do an Inspection Audit on site Depending on the category of the license the building and its equipment are subject to different requirements Manufacture license categories Type No 1 Animal Origin Devices PAL Article 43 Type No 2 Sterile Devices Type No 3 Other than No 1 and No 2 Other general devices Type No 4 License for Labeling Packaging and storage 106 HERMON LABORATORIES Accreditation of Foreign Manufacturer by PMDA A person intending to manufacture in foreign countries drugs or medical devices etc that are imported to Japan may be accredited by the Minister as a foreign manufacturer Accreditation is granted for each site according to the categories Accreditation shall be renewed every 5 years n H HERMON LABORATORIES 107 Certification Process by Third Party Certification RCB Approval Shonin of Medical Device by PMDA Certification Ninsho of Medical Device Dy HCB Re
45. the corres bonding row of column 4 with description of the actions the RESPONSIBLE ORGANIZATION or OPERATOR must take to reduce the environmental levels of the ELECTROMAGNETIC DISTURBANCE 50 that they are less than or equal to the COMPLIANCE LEVEL listed in column 3 ls the COMPLIANCE LEVEL lower than the IEC 60601 TEST LEVEL In Table 2 the text in the corresponding row af column 4 may be replaced with for which the ME EQUIPMENT ar ME SYSTEM i5 suitable Guidance and manufacturer s declaration RF fields IMMUNITY Guidance and manufacturer s declaration electromagnetic immunity ME EQUIPMENT SYSTEM is Intended for use in the electromagnetic environment specified below The customer or the user of the ME EQUIPMENT Or ME SYSTEM should assure that it is used in such an environment IMMUNITY test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 NOTE 1 IEC 60601 TEST LEVEL 3 Vrms 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5 GHz Compliance level 4 vim Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the EQUIPMENT Or ME SYSTEM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance p V1 d WP 80 MHz to 800 MHz 1 d MP 800 MH
46. ude RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment 5 1 2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts for which the connector testing do exemption specified in 6 2 2 2 c is used 5 1 3 Marking on the outside of ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location m Li HERMON LABORATORIES Section 5 Identification marking and documents ACCOMPANYING DOCUMENTS section 5 2 5 2 2 1 Requirements applicable to all EQUIPMENT 5 2 2 2 Requirements applicable to EQUIPMENT other than those specified for use only in a shielded location 5 2 2 3 Requirements applicable to EQUIPMENT specified for use only in a shielded location 5 2 2 4 Requirements applicable to that intentionally apply RF energy for diagnosis or treatment 5 2 2 5 Requirements applicable to EQUIPMENT that intentionally receive RF electromagnetic energy for the purpose of their operation 5 2 2 6 Requirements applicable to EQUIPMENT that include RF transmitters 5 2 2 7 Requirements applicable to cables transducers and other ACCESSORIES 5 2 2 8 Requirements applicable to LARGE PERMANENTLY INSTALLED EQUIPMENT 5 2 2 9 Requirements applicable to EQUIPMENT found to have no ESSENTIAL PERFORMANCE 5 22 10 Requirements applicable to TYPE A PROFESSIONAL L E QUIPMENT HERMON LABORATORIES A list of all cables and maximum lengths of cables if applicab
47. ues need be considered Where the probability of multiple faults is high enough e g due to water spillage inadequate design for ageing or corrosion then two or more independent faults could occur with sufficient likelihood and can even be considered WORST CASE of NORMAL OPERATION General rule is failure of anything less than one MOP means of protection is considered NORMAL OPERATION HERMON LABORATORIES The reliability of components that are used as MOP shall be assessed for the conditions of use in the product They shall comply with one of the following e the applicable safety requirements of a relevant IEC ISO or national standard e where there is no relevant IEC or ISO standard the requirements of this standard have to be applied Example Gaskets and Seals shall comply to IEC60950 22 National Standards UL50E and UL 157 Testing for IP protection without gaskets if gaskets are not approved m n HERMON LABORATORIES Compliance Standards and Tolerable Risks Achieving regulatory approval for a given market does not necessarily guarantee that a product has tolerable safety risks Product liability and safety laws exist in all developed countries These laws vary in their application in different countries due to their different legal traditions and they may vary between different states within the U S and even between different counties within a state H HERMON LABORATORIES
48. vel Conditions of acceptability Installation instructions and user manual of components and sub assemblies must be obtained and reviewed H HERMON LABORATORIES Component selection for CB and NRTL approval UL is not worst case for fuses cables and power supplies any longer Using components approved to National Standards only like UL 60601 1 for power supplies can prevent obtaining CB Report CB and NRTL approval status for components and sub assemblies should be provided ahead of investigation If component approvals are adequate and acceptable CB NRTL and CE projects should take the same timeframe Acceptance of construction or component is very much dependant on certification path Watch latest developments in IEC component standards HERMON LABORATORIES Zoom in Laser Products There were no general requirements for most Radiation Hazards 27 Edition Normal procedure is to add IEC 60825 1 as amendment but not to mention it anywhere in CE DoC or on NRTL Certificate 3 d Edition requires compliance with IEC 60825 1 1993 superseded 2005 New 60601 1 22 applies to laser equipment for either surgical therapeutic medical diagnostic cosmetic or veterinary applications intended for its use on humans or animals classified as a class 3B or class 4 laser product as defined by 3 22 and 3 23 in IEC 60825 1 HOW THE LASER WORKS 1 The laser is di
49. z Life support Voltage dips and 61000 4 11 interruptions 500 ms 5000 ms Applies only to ports which may be connected to cables longer than 3 meters Applies only to ports which are connected to cables longer than 1 meters Test CO n d n S Interpretation sheet SC 62A Publication IEC 60601 1 2 2007 3 3 edition I SH 01 Test name Test conditions Emissions S Electrostatic discharge ESD At any nominal power voltage frequency one is enough Radiated RF EM fields Rl At any nominal power voltage frequency one is enough Electrical fast transients and At the minimum and maximum nominal voltages any bursts EFT B operating frequency Surges At the minimum and maximum nominal voltages at any operating frequency Conducted RF EM fields At any nominal power voltage frequency one is enough Voltage dips short interruptions At the minimum and maximum nominal voltages but at the and variations minimum power frequency 50 Hz only At all nominal power frequencies but at any power voltage same frequency as applied field Magnetic fields Non medical electrical equipment Section 4 1 2 Electrical equipment that is not ME EQUIPMENT and that is supplied as part of an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard provided that the following conditions are met the electrical equipment that is not ME EQUIPMENT compl
50. z to 2 5 GHz E1 where F is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol O At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength the location which the EQUIPMENT ME SYSTEM Is used exceeds the applicable RF compliance level above the ME EQUIPMENT or SYSTEM should be observed to verify normal operation abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ME EQUIPMENT ME SYSTEM Over the frequency range 150 kHz to 80 MHz field
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