TITLE OF THE CD (English): Revision OIML R 126 TITLE OF THE
Contents
1. 2 11 2 12 2 13 2 14 Portable breath alcohol analyser A breath alcohol analyser which operates with an autonomous battery It may be used in or outside buildings or mobile applications Alveolar air Air contained in the pulmonary alveoli where the gaseous exchange takes place between the arterial blood and the gas contained within the alveoli End expiratory breath Air considered sufficiently representative of alveolar air in opposition to dead anatomical volume dead anatomical volume Conducting area of gas flow known as area of conduction without exchange of an average volume of 150 ml Measuring mode The clearly indicated mode in which the breath alcohol analyser can make measurements at the rate normally expected in service and in which it shall meet the performance requirements of this Recommendation Maintenance mode The mode in which the breath alcohol analyser can be adjusted and subject to metrological testing and control Stand by mode The mode of the breath alcohol analyzer which only certain circuits are energized in order to conserve power and or prolong component life and to attain the measuring mode more rapidly than would be possible if starting from the un powered state Adjustment device A device for adjusting the breath alcohol analyser when it is in maintenance mode Fault OIML D11 3 9 Difference between the error of indication and the intrinsic error of a measuring instrument2. Significant fault OIML D11 3 10 Fault greater than value specified in this Recommendation Disturbances An influence quantity having a value outside the specified rated operating conditions of the measuring system If the rated operating conditions are not specified for an influence quantity it is a disturbance 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 7 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 2 15 2 16 2 17 Built in automatic checking facility A device which allows verifying by involving all relevant internal elements that the breath alcohol analyser is suitably adjusted Such a device may include internal checking elements for example signal stability temperature stability or additional checking external elements to be connected to the instrument such as optical or electrical filters or cylinder with a known concentration test gas Drift The change in the result of a measurement of the same alcohol concentration which occurs during a stated period of time at a given mass concentration of ethanol in air Memory residual effect The difference between the results of measurement of the same alcohol concentration when delivered samples are interposed with a sample containing a specified higher alcohol concentration 3 Metrological requirements 3 1 3 2 Reliability of the measurement The breath alcohol analyser shall be designed such that a measurement result is
3. after the time interval specified under 3 6 again 10 subsequent measurements For each drift test the deviation between the mean value of the two series of measurements shall fulfil the requirements for drift 3 6 Other tests for type approval may be performed during the drift tests Memory and residual effect 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 18 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 4 3 1 Memory effect The breath alcohol analyser shall be subjected to an initial test that includes 10 measurements using test gas n 2 The mean value of these 10 measurements is calculated Then the breath alcohol analyser shall be subjected 10 times to the following cycle e one measurement using test gas n 7 or n 8 which ever greater e one measurement using test gas n 2 The mean value of these 10 measurements with test gas n 2 during the cycle is calculated For the mass concentration at 0 10 mg L the difference between the two calculated mean values shall be less than the limit specified in 3 7 1 A 4 3 2 Small changes in mass concentration The breath alcohol analyser shall be subjected to 10 measurements using test gas n 4 The mean value of these 10 measurements is calculated Then the breath alcohol analyser is subjected to 10 measurements using test gas n 3 The mean value of these 10 measurements is calculated The difference between these two mean values shall co
4. B 2 Two measurement cycle B 3 Delay before measurement Annex C General information and breath profile informative Annexe D Test Report Format 3rd Committee Draft Recommendation on Breath Alcohol Analysers 16 16 16 16 18 19 20 23 23 27 28 28 28 30 31 37 Page 5 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 1 Requirements Scope This International Recommendation applies to quantitative breath alcohol analysers which are instruments that automatically measure the mass concentration of alcohol in exhaled human breath representative of the level of alcohol intoxication of the subject For the purpose of this recommendation only ethanol is considered as alcohol This Recommendation does not apply to instruments which do not quantitatively indicate the result of measurement but which only indicate whether the mass concentration of alcohol exceeds the allowed limits Additionally national authorities may require that breath alcohol analysers are equipped with special devices according to the national policy for fighting against alcohol abuse For example e Device s that detects the presence of alcohol in the upper respiratory tracts prohibition of display or printing of results which do not represent the final measurement result e making mandatory a printing device e making the measurement impossible in case of no paper is detected in the printing device e requiring additional printed in
5. Breath Alcohol Analysers Page 17 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 3 3 performing tests defined in Annex A 6 corresponding to the breath profile describe to Annex A 2 Accuracy tests The apparatus shall be of one of the two following types Type 1 the apparatus delivers constant concentration curves Type 2 the apparatus is similar to the one corresponding to A 3 1 During tests the plateau shall be reached when half of the test volume has been injected 10 of total volume A 4 Accuracy tests A 4 1 A 4 2 A 4 3 Maximum permissible errors and repeatability Compliance with maximum permissible errors requirement defined in 3 3 1 and repeatability requirement defined in 3 5 shall be verified at least at the following nominal values Test gas n Mass concentration mg L 1 0 00 to 0 05 2 0 10 3 0 25 4 0 40 5 0 70 6 7 8 0 95 1 50 2 00 mg L or the upper value specified by the manufacturer For type approval at least 20 measurements shall be made consecutively at each gas concentration For each test gas each of the 20 measurement results shall comply with the maximum permissible error requirement Drift The compliance with the drift requirements shall be tested at certain gas concentrations Zero drift Test gas n 1 Drift at 0 4 mg L test gas n 4 Test procedure for each test gas 10 subsequent measurements
6. Maximum permissible errors for breath alcohol analysers in service for the subsequent verifications 8 of the true value of mass concentration or x mg L whichever the greater for all mass concentrations over the measuring range x is a fixed value which is defined by National Authorities and which shall not be less than 0 02 mg L 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 9 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 3 4 Disturbances and other influence quantities 3 4 1 Disturbances In the presence of a disturbance the breath alcohol analyser shall display no significant fault The significant fault is equal to the magnitude of the maximum permissible error applicable to type evaluation for the following disturbances e Radiated radiofrequency electromagnetic fields A 8 1 e Conducted radiofrequency fields A 8 2 e Electrostatic discharges A 8 3 e Bursts on supply lines A 8 4 e Bursts on signal data and control lines A 8 5 e Surges on signal data and control lines A 8 6 e AC mains voltage dips short interruptions and voltage variation A 8 7 e Electrical transient conduction for external batteries of a vehicle A 8 8 e Mechanical shocks A 8 9 e Shakes A 8 10 e Damp heat cyclic A 8 11 e Storage A 8 12 The corresponding tests are described in the Annex A 8 3 4 2 Other influence quantities 3 4 2 1 Physiological influence quantities The correspondin
7. The printing device shall be equipped with an automatic checking facility to verify the correct transmission of the data from the breath alcohol analyser to the printing device At least the following shall be checked 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 12 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 4 4 4 5 4 6 presence of paper the electronic control circuits When the printing device is not included into the measuring instrument the National Authorities shall defined the requirements to prevent intentional and accidental modification of the data during their transmission Measuring conditions At least before each measurement the instrument shall automatically adjust or check adjustment implementing the built in automatic checking facility The instrument shall indicate a zero with a tolerance 0 005 mg L using an appropriate purge When this adjustment is not possible or this check gives negative results the instrument shall indicate an alarm and shall not allow any further measurement The breath alcohol analyser shall indicate its readiness to start a measurement and shall not perform measurements when it is not ready When after a period of time the instrument is no longer ready to perform measurements it shall indicate this The breath alcohol analyser shall monitor the continuity of exhalation and shall give an indication if the flow of exhaled air is interrupte
8. alcohol analyser has no mains or input ports the applicable frequency range is from 26 MHz to 2000 MHz The frequencies are stepped across incrementally with the step size not exceeding 1 of the previous frequency A 8 2 Conducted radio frequency fields See OIML D 11 12 1 2 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 23 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 8 3 A 8 4 A 8 5 A 8 6 This test doesn t apply if the breath alcohol analyser has no mains or other input ports Otherwise it shall be conducted on supply lines and on all connection cables if the instrument is composed of several elements connected together For connection cables the test shall be performed at each extremity of the cables if both of the elements are part of the instrument The test conditions are the following Frequency range from 0 15 MHz to 26 MHz Modulation 80 AM 1 kHz sine wave e RF amplitude 50 Q 10V Electrostatic discharges See OIML D 11 12 2 Contact discharges are the preferred test method Nevertheless air discharges shall be used where contact discharges cannot be applied e g non conductive surfaces Both types of application shall be performed e Direct application Indirect application The discharges shall be applied on each surface accessible in normal operation 5 measurements shall be performed in each surface At least ten successive discharges shall
9. be applied with a time interval between discharges of at least ten seconds on each point of application The number of points of application on each surface will depend on the size of the instrument and shall be specified in the test report The test conditions are the following Test voltage for contact discharge 6 kV Test voltage for air discharge 8 kV Bursts on supply lines See OIML D 11 13 5 This test is only applicable to breath alcohol analyser powered from AC mains or DC mains The test consists of exposure to bursts of voltage spikes of 1 kV Each spike shall have a rise time of 5 ns and a half amplitude duration of 50 ns The burst length shall be 15 ms and the burst period repetition time interval shall be 300 ms At least ten positive and ten negative bursts randomly phased shall be applied Bursts on signal data and control lines See OIML D 11 12 4 Both positive and negative polarity of the bursts shall be applied Amplitude peak value 1 kV Repetition rate 5 kHz Surges on signal data and control lines See OIML D 11 12 5 At least 3 positive and 3 negative surges shall be applied The injection network depends on the lines the surge is coupled into 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 24 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 8 7 A 8 8 A 8 9 Line to line 1kV Unbalanced lines Line to earth 2kV Balanced l
10. concentration during injection The completed test reports shall indicate when such alternative tests have been implemented For tests other than those for accuracy and to demonstrate the capability of the breath alcohol analyser to make measurements on the end expiratory air the following simplified means could be used e Dry gases which can be used for tests defined in A 6 4 A 6 5 A 6 6 A 8 1 to A 8 10 included e Gases without CO2 which can be used for tests defined in A 6 A 8 In all cases the evolution of the concentration and the flow rate during injection may be constant For cases involving dry gases in cylinders e variations of atmospheric pressure and variation of the compressibility factor between filling and usage conditions must be taken into account e the quality of the gas regulators and the manner by which it is delivered to the breath alcohol analyser should be taken into account to minimize contamination and a change in the composition of ethanol throughout its use cycle e test facilities must be taken into account in calculations of the uncertainties of the measurement Demonstration of the capability of the breath alcohol analyser to make measurements of end expiratory breath In order to demonstrate the capability of the breath alcohol analyser to make measurements on the end expiratory breath the apparatus used by the laboratory shall permit be capable of 3rd Committee Draft Recommendation on
11. curves By considering an average dead anatomical volume of 150 ml a theoretical curve of the alcohol concentration expressed in according to time and volume of the breath can be calculated starting from the following formula C Cyy D 100 cu t lay m C 9 i incremental indice where C alcohol concentration expressed in D flow rate L s t time of exhalation s Vm dead anatomical volume L note this is a reference to the volume of air from the upper respiratory tract In theory the alcohol concentration representative of alveolar air is obtained in the last third of the time of expiry concentration superior to 99 of the maximum value This value 99 of the waiting concentration is a proposition based on the statistic rules about response time Another value can be proposed for example 99 5 This value and its variations must be taken into account in the global calculation of the overall uncertainty of the test facility in accordance with the requirement of chapter A 3 Note 1 3 EMT Example by considering an average dead anatomical volume of 150 ml Example curve A breath Profile 2 5 Lin 5 s constant breath Dead volume 150 mL 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 33 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 simulation of a curve C f t breath 2 5 Lin 5s flow rate 0 5 L s dead volume 150 mL plateau reached for a conc
12. representative of the alcohol concentration present in the end expiratory breath In order to demonstrate the conformity to this requirement the breath alcohol analyser shall fulfil the requirements in 3 2 3 and the tests in A 5 Rated operating conditions 3 2 1 Measuring range The breath alcohol analyser shall be capable of measuring all mass concentrations in the range 0 00 mg L to at least 2 00 mg L However in the measuring mode the breath alcohol analyser may indicate 0 00 mg L for mass concentrations equal to or smaller than a given value defined under the responsibility of national authorities Such a masking function shall be able cancelled in maintenance mode The greatest permissible value for the upper limit of the measuring range is 3 00 mg L The breath alcohol analyser shall indicate when its upper limit of measurement is exceeded The scale interval is 0 01 mg L in the measuring mode Nevertheless in the maintenance mode it shall be possible to display a scale interval equal to 0 001 mg L 3 2 2 Physical influence factors The rated operating conditions corresponding to the physical influence factors are specified in A 6 for the following performance tests e Dry heat A 6 1 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 8 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers August 2007 e Cold A 6 2 e Damp heat steady state A 6 3 e Random vibrations A 6 4 e Power voltage v
13. 2 14 2 15 2 16 2 17 Metrological requirements 3 1 3 2 1 3 1 4 1 5 1 6 1 7 1 8 Technical requirements 4 1 4 2 4 3 4 4 Mobile breath alcohol analyser ccecccessceesceeseeeceeeeeeteeeseeeseeensees Portable breath alcohol analyser cccccscesscceseceseceeeceeeeeteeeseeeseeaees Alveolar ate en eene gsi juss E EA E veaetaenes End expiratory breath sseeesseseesseseessossessesesseesseserssessessessesseesssseesse dead anatomical volume ssssssesssesesesessessesesstssstsersesrssrsesessesesresesse Measuring mode ccccecccccsseessecseceneceeceseceseceeecseeeseeeesseeeseeeseeesaeesaees Maintenance mode esssesseessssseseessseseserstssesesststsststesessseseesesseseseesesst Stand by Moderen anara aea a EEE E ta TA NA aR Adjustment device eanit i a i a Fault OIME DIT 3 9 r nin E EEE Significant fault OIML D11 3 10 oo ec cecceceesseeeteceteceteeeteeeseeenes Disturbances esciisncsiave S E EEE E Radke eee as Memory residual effect ccceccccsccesscessceeseeeeeeeeeeeeeeeeeeteeeseeesees Reliability of the measurement ccccccceseeeeceeeeeeeeeeeeteeeseeeteeeaees Rated operating conditions eeceseeseeeeeeeceeeeeeeeeeeseceeeeeeaecnaeeneeeees Maximal permissible errors MPE ceccesceceeeseeeceeeeeeeecneeeneeeees Disturbances and other influence quantities cccccceesseeseeteeeees Memory and residual effect cccccesccessceseceeeceeeeeeeeeeeeeeeeseees
14. TC 17 SC 7 Breath Alcohol Analysers August 2007 COMMITTEE DRAFT OIML CD3 Date 20 April 2007 Reference number Supersedes document OIML R 126 CD2 OIML TC 17 SC7 Title OIML R 126 Breath alcohol analysers Secretariat TC 17 SC 7 France Circulated to P and O members and liaison international bodies and external organisations for discussion planned at a meeting to be held on April 2008 to be confirmed comments by vote P members only and comments by TITLE OF THE CD English Revision OIML R 126 Breath alcohol analysers TITLE OF THE CD French Ethylom etres Original version in English 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 1 37 TC 17 SC 7 Breath Alcohol Analysers TC17 SC 7 SECRETARIAT FRANCE P Members AUSTRALIA AUSTRIA BELGIUM BRAZIL FRANCE GERMANY NETHERLANDS NORWAY POLAND ROMANIA RUSSIAN FEDERATION UNITED KINGDOM UNITED STATES O Members BULGARIA CANADA CZECH REPUBLIC DENMARK FINLAND HUNGARY IRELAND JAPAN SERBIA AND MONTENEGRO SLOVAKIA SLOVENIA SWEDEN SWITZERLAND Liaisons IEC International Electrotechnical Commission ISO International Organization for Standardization 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 2 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers CONTENT 1 2 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 2 10 2 11 2 12 2 13
15. TC 17 SC 7 Breath Alcohol Analysers For each test condition and each measurement the maximum permissible error requirement specified in 3 3 1 shall be fulfilled Nevertheless in the test at the extreme value of hydrocarbons in the environment it is acceptable that the breath alcohol analyser gives no result A 6 1 Dry heat See OIML D 11 10 1 1 The tests consists of exposure of the breath analyser to a temperature defined below according to type of breath alcohol analyser under free air conditions for a two hours period after the breath alcohol analyser reached temperature stability Stationary Mobile Portable Temperature 30 C 40 C 40 C or 50 C Duration 2 hours Number of cycle 1 Specified by the State August 2007 A 6 2 Cold See OIML D 11 10 1 2 The tests consists of exposure of the breath analyser to a temperature defined below according to type of breath alcohol analyser under free air conditions for a two hours period after the breath alcohol analyser reached temperature stability Stationary Mobile Portable Temperature 5 C 10 C 25 C or 10 C Duration 2 hours Number of cycle 1 Specified by the State A 6 3 Damp heat steady state non condensing See OIML D 11 10 2 1 The tests consists of exposure of the breath alcohol analyser to the specified high level of temperature and the specified constant relative h
16. a Humidity 95 HR in the pressure condition during the breath Presence of CO 5 Display The result of measurement shall be displayed digitally by means of aligned figures The display in the measuring mode shall consist of the display in metrological testing mode rounded down to 0 01 mg L e g a measured value of 0 427 mg L shall be displayed as 0 42 mg L The height of the figures on the display shall be equal to at least 5 mm for illuminated displays 10 mm in all other cases The name of the unit of measurement or its symbol shall appear in close proximity to the measurement indication The characters used shall be at least 3 mm high If the characters are not illuminated the display shall have an illumination device Printing device The breath alcohol analyser may be equipped with a printing device which print at least the result of the measurement e the symbol of the unit in which the result is expressed If the printing device is in the scope of the type approval the printing device shall operate during the influence factors and disturbances The printed result shall not differ from the indicated one displayed by the indicating device If the symbol of the unit is pre printed the paper shall be especially prepared for the printing device Printouts shall remain readable for at least thirty days even when exposed to daylight or equivalent lighting The manufacturer shall recommend a paper type
17. as defined in Annex A 4 3 7 Memory and residual effect 3 7 1 Memory effect The memory effect shall be less than 0 010 mg l when the test is conducted according to A 4 3 1 3 7 2 Small changes in mass concentration The error in the result obtained with a gas having a mass concentration which is 0 10 mg L less than that of another gas previously injected shall be less than or equal to the maximum permissible error for the lower mass concentration 3 8 Durability All the tests specified in this recommendation shall be performed on the same instrument in order to demonstrate the durability of the instrument 4 Technical requirements 4 1 Physical quantity and unit of measurement The breath alcohol analyser shall display measurement results in term of mass concentration of alcohol in a specified volume of exhaled air The mass concentration shall be indicated in milligram per litre of exhaled breath mg L The national authorities may require to use an equivalent unit of measurement if the indication is in conformity with the legal international units and as long as it represent a 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 11 37 TC 17 SC 7 Breath Alcohol Analysers 4 2 4 3 mass concentration of alcohol in a specified volume of exhaled air The reference conditions for all measurement alcohol concentration including calibration are Temperature 34 0 C Pressure Patm during the tests hP
18. d between the beginning and the end of the sampling A signal preferably audible shall indicate the continuity of the exhalation When a measurement result is nil it shall not be possible to confuse such a result with the zero indication prior to measurement The breath alcohol analyser shall be equipped with a function which automatically detects whether the measuring result is affected by the presence of alcohol in the upper respiratory tracts Examples of compliance are given in Annex B The user shall not have access to the maintenance mode nor to the adjustment device Checking operations When powered on the instruments shall automatically check their correct operation e g checksums watchdogs etc When any defect or an error signal is detected the instrument shall indicate an alarm and shall not allow any further measurement EBA s shall check correct operation automatically both before each measurement and after any measurement which gives a result greater than a predetermined value of the mass concentration this value may be zero Suitability for use 4 6 1 Warm up time Under reference conditions 3 2 3 the breath alcohol analyser shall be capable of attaining the measuring mode e 15 minutes after being switched on e 5 minutes after switching from stand by mode to measuring mode However if these requirements are not fulfilled the corresponding times shall be marked on the breath alcohol analyser and provi
19. ded in the user manual 4 6 2 Availability for measurement 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 13 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 4 7 4 8 After successful checking operation including automatic checking of adjustment using the built in automatic checking facility from the moment the breath alcohol analyser indicates that it is ready to receive an exhalation the breath alcohol analyser shall be available at least one minute After a period time not using the instrument it is no longer ready to perform a measurement and it shall indicate that 4 6 3 Availability of the measurement result It shall be possible to retain the results in a readable or accessible form for at least 15 minutes If other measurements can be performed during the period the previous result shall be accessible without ambiguity If this requirement can be met only by printing the results the absence of paper in the printer shall prevent measurement being made Marking and sealing The breath alcohol analyser shall be marked with a tamper evident label on a visible part of the instrument with the following information type approval mark manufacturer s name denomination of the instrument serial number e measurement range stationary mobile or portable ambient conditions power supply range Appropriate seals shall protect the integrity of the instruments P
20. e 3 L 0 2 L e duration ofinjection 5 s 0 5 s e type of profile constant flow rate e Second test e delivered volume 3 L 0 2 L e duration of injection 5s 0 5 s e type of profile forceful expiry according to annex C1 Influence of the flow rate in conjunction with volume e First test e Delivered volume 1 5 L 0 1 L e Duration of injection 5 s 0 5 s e Second test e Delivered volume 4 L 0 2 L e Duration of injection 5 s 0 5 s Influence of interruption in the breath flow e First test the injection of gas normally required for the reference conditions specified in A 3 shall be stopped 1 0 5 s after the start of injection e Second test the injection of gas normally required for at least 15 s see A 5 2 shall be stopped at 6 1 s after the start of injection e Third test short flow interruption The injection of gas supplied at a flowrate equal to 0 15 L s is decreased at a flow rate equal to 0 03 L s For these 3 tests the instrument shall not give a result A 6 Physical influence factors The effect of each influence factor shall be determined separately and influence factors not under investigation shall remain at their reference values as specified in A 4 The tests shall be carried out using test gas n 4 At least 5 measurements shall be performed in each test condition 3rd Committee Draft Recommendation on Breath Alcohol Analysers August 2007
21. eeesees Dyna ah FIA AAE ecdaeh sex sateeg E ead eadansd soa E E Physical quantity and unit of measurement ee eeeeseeteceeeeeeeees DS a ENE E T TRT EE ET PrimtinS SAA O EAA EA EEEE EEA Measuring conditions cccesecessceseceteceeceeceeeceeeeeeeeeeseesseeeseeesaeestees 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 3 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers August 2007 4 5 Checking Operations 1 23 cd eadseciore a a E E A he hv A e Bowe 13 4 6 Suitability fOr Use cers eczaivsse cab consaceakasstPoky EEEE E E E E E E E i 13 4 7 Marking and sealin gisona an a a A dank E E A 14 4 8 Physical mean to filter the cleaning aif oo ccc eecceseceseceseceeeceeeeeeeeeeseeeseeeseecsecnseeseeeseeeeneeeses 14 4 9 Safety and Security rrea t sabes bis Set se cahatsan nc ara aaa acd Weave eek estaba 15 S gt Pype approval supren nE Ei Ta e a sees EEE e OEE iaaa e e ra TRE Eaa 15 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 4 37 TC 17 SC 7 Breath Alcohol Analysers Annex A PERFORMANCE TESTS A l A 2 A3 A4 A S A 6 A 7 A 8 A General Breath profile Test facilities Accuracy tests Influence factors in the parameters which characterise the test gases Physical influence factors Influence of volume fraction of CO Disturbances tests Physiological influence quantities Annex B Examples of detection of alcohol in upper respiratory tracts B 1 Peak method
22. entration 99 0 after 2 0s 100 00 se 80 00 E Q 60 00 5 40 00 c 8 20 00 0 00 0 1 2 3 4 5 time s Concentration Example curve B breath Profile 2 0 L in 5 s constant breath Dead volume 150 mL simulation of curve C f t breath 2 L in 5 s flow rate 0 4 L s dead volume 150 mL plateau reached for a concentration 99 0 after 1 7 s 100 00 se 80 00 c 2 60 00 5 8 40 00 8 20 00 0 00 Temps s Concentration Example by considering an average dead anatomical volume of 300 ml Example curves C 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 34 37 TC 17 SC 7 Breath Alcohol Analysers breath Profile 2 5 L in 5 s constant breath Dead volume 300 mL simulation of a curve C f t breath 2 5 Lin 5s flow rate 0 5 L s dead volume 300 mL plateau reached for a concentration 99 0 after 2 7 s 100 00 se 80 00 c Q 60 00 5 8 40 00 f 8 20 00 0 00 0 time s Concentration Example curves D breath Profile 2 0 Lin 5 s constant breath Dead volume 300 mL 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 35 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers Augu
23. ests including repeatability drift and memory and residual effect Influence factors e Disturbance tests The tests specified in this Recommendation constitute minimum test procedures Further tests may be undertaken if necessary in order to clarify issues of compliance of the breath alcohol analyser with the requirements of this document A 2 Breath profile The human breath containing alcohol may be considered corresponding to the following characteristics e Evolution of the alcohol concentration during the breath The evolution of the breath of a human being is characterized by a plateau in the curve of mass concentration against time during the last part of the exhalation The mass concentration at this plateau represents the mass concentration in the end expiratory breath Annex C2 shows the general form of this breath profile e Evolution of the flow rate curve during the breath Annex C1 shows the general form of this breath profile A 3 Test facilities The apparatus shall be able to determine the true value of the mass concentration with an uncertainty less than or equal to one third of the maximum permissible error for example expressed at a level of confidence of about 95 calculated with k 2 This uncertainty includes the components of uncertainty on the determination of the plateau Taking into account of the testing apparatus the tests shall be conducted with the maximum frequency allowed by the breath alco
24. formation National authorities may require that the breath alcohol analysers convert and display measurement result obtained in terms of ethanol content in the exhaled human breath either into physiological conditions or in terms of other quantities This Recommendation does not cover the metrological performance of such devices The purpose of this Recommendation is to specify the minimum metrological specifications and tests applicable to type approval initial verification and in service verification of breath alcohol analysers owing to national differences in legal systems Terminology 2 1 Breath alcohol analyser An instrument that measures within specified error limits and displays the breath alcohol mass concentration by analysing exhaled human breath representative of the level of the alcohol intoxication of the subject 2 2 Stationary breath alcohol analyser A breath alcohol analyser intended only for use within buildings or places providing stable environmental conditions 2 3 Mobile breath alcohol analyser A portable breath alcohol analyser intended for use in mobile applications e g in cars However it is advisable that national penal law defines offences in terms of alcohol in breath so that these instruments are more appropriately used 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 6 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 2 4 2 5 2 6 2 7 2 8 2 9 2 10
25. g test and acceptance criteria are specified in A 9 interfering substances and A 7 volumetric fraction of CO 3 4 2 2 Influence of substance in ambient air The instrument shall not exceed the MPEs in the presence of hydrocarbons in the ambient air corresponding to a total fraction by volume of hydrocarbons as methane equivalent equal to 5 ppm 3 5 Estimation of the repeatability 3 5 1 Experimental standard deviation The experimental standard deviation is given by the formula 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 10 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 where n the number of measurements made at a given mass concentration Yi the ith measurement out of n for the given mass concentration Y the arithmetic mean of the n values 3 5 2 Requirement applicable to the type approval and the initial verification The experimental standard deviation for all mass concentrations shall be less or equal to one third of the maximum permissible error 3 6 Drift 3 6 1 Zero drift The drift from 0 00 mg L shall be less than 0 010 mg L in 4 hours under reference conditions as defined in Annex A 4 3 6 2 Drift at 0 40 mg L 3 6 2 1 Short term drift the drift at 0 40 mg L shall be less than 0 010 mg L in 4 hours under reference conditions as defined in Annex A 4 3 6 2 2 Long term drift the drift at 0 40 mg L shall be less than 0 020 mg L in two months under reference conditions
26. hat it has been cleared from the upper respiratory tract A delay of 15 min is a reasonable limit if combined with an other method as defined in A1 or A2 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 30 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers Annex C General information and breath profile informative explanatory Note The study of the human behaviour in front to a control of blood alcohol content and its physiology shows a great diversity on the manner and the capacity of an individual to carry out a breath voluntarily or not in a EBA If it is easy to take into account and to fix the following factors of influences volume time of expiry it is more complicated to rule on problems of flows and determination of plate of alcohol concentration Indeed it is obvious that the variation of the flow of expiry of the pressure at the time of a breath will be very different while realizing a long and regular breath flow at the time of the constant breath or presenting a very light decrease a dynamic and short breath peak of the flow at the beginning of the breath and fast decrease at the end of the breath Knowing that the instruments can be influenced by variations of pressure at the time of a breath it is important to consider this new factor of influence Same manner the taking into account of different the volume died from the physiological point of view from the individuals highlig
27. he chapter A 8 1 A 8 2 A 8 8 in witch the measurements shall be made during all the disturbances test s For each disturbance test unless otherwise specified the difference between the result of the test and the performance at reference conditions shall not exceed the significant fault value specified in 3 4 1 It is acceptable that the breath alcohol analyser gives no result during the disturbance testing The error of the instrument is generally determined during the disturbance except for mechanical shocks A 8 9 shakes A 8 10 and storage test A 8 12 When several test configurations are specified for one disturbance test the fault shall be determined for each of these configurations The application of each test shall be long enough to apply during a complete cycle of measurement of the breath alcohol analyser For the tests specified in A 8 1 to A 8 3 conventionally 3 cycles of tests are performed starting each test at different moment of the measuring cycle A 8 1 Radiated radio frequency electromagnetic fields See OIML D 11 12 1 1 The breath alcohol analyser shall be exposed to electromagnetic field strength as specified hereafter Frequency range from 80 MHz to 2000 MHz Modulation 80 AM 1 kHz sine wave Field strength 10 V m This test includes the susceptibility to electromagnetic fields of general origin and to those specifically caused by digital radio telephones In the event that the breath
28. hol analyser The breath alcohol analyser may be completely calibrated if necessary by the manufacturer before type approval testing begins Thereafter no adjustment shall be carried out until all type approval testing is complete 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 16 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers A 3 1 A 3 2 Characteristic reference values of the test gas Unless otherwise specified the test gas injected continuously into the breath alcohol analyser shall be characterised by the following parametric values e Delivered volume 2 L 0 3 L e Total duration of injection into breath analyser 5 s 0 5 s e Type of profile constant flow rate e Relative humidity of the gas at least 90 at the exit way pressure of the instrument e Gas temperature 34 C 0 5 C e carrier gas air containing insignificant concentrations of relevant impurities with volumetric fraction of CO 5 1 The completed test reports shall indicate what kind of test means has been used for each test Test reports shall indicate when other gases were used and how their equivalence with the reference gases was established Simplified means This Recommendation permits the use of calibration gases produced by simplified means for some tests Such means may consist in the use of dry gases or wet gases generated by simple test means e g the absence of CO in test gases constant mass
29. ht a dilution of the alcohol concentration contained in the air cells representative of the alcohol concentration contained in blood and the volume of the high respiratory tracts free from alcohol or more precisely if one considers a presence of alcohol on the mucous membranes that Ci no representative of alcohol is contained in the air cells Present the appendix aims at to present using theoretical curves the physical phenomena allowing to characterize the influence factors to prepare the next ones discussed in order to rule on the types of profiles and the criteria of acceptances C 1 MEASUREMENT FLOW RATE DURING EXHALATION The object of this chapter is to define a method making it possible to fix characteristics for the determination of the variation of the air flow at the time of an expiry This chapter relates to mainly the test facilities and relates to the definitions of the breaths of tests Curves of the flow rate as a function of volume obtained from a human exhalation 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 31 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers August 2007 Conventional curve of forced exhalation The curve is divided into two distinct areas e the first part of the curve located in the first 1 4 of the time of exhalation represents the peak of flow at the time of the exhalation e the second part represents a regular decrease of the flow of breath recordi
30. hysical mean to filter the cleaning air It shall be possible to change this mean without removing any sealing device if the filter is a particle filter For any another type of filter the manufacturer shall define the periodicity of this replacement The replacement is considered as repairing operation To replace this filter it shall be necessary to break the sealing device 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 14 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers 4 9 Safety and security The EBA shall be capable of being used under satisfactory hygienic conditions It shall be possible to change the mouthpiece for each measurement mouthpieces shall be individually packaged EBA s shall conform to relevant national regulations and standards for electrical safety and where appropriate for compressed gases Verification of compliance with these regulations and standards is not within the scope of this Recommendation The EBA breath sampling system including the mouthpiece shall not allow the subject of the measurement to inhale contaminated air from previous usages It shall prevent the deposition of droplets from exhaled breath in the EBA 5 Type approval Manufacturers shall provide the technical documentation a user manual for the breath alcohol analyser and the description of the adjustment procedure Other information may be provided such as information on performance tests on calibrat
31. ibrations A 6 5 e Frequency vibrations A 6 6 e Influence of atmospheric pressure A 6 7 3 2 3 Conditions of exhalation The breath alcohol analyser shall indicate whether the conditions of exhalation e g continuity and flow complied with the conditions specified by the manufacturer in order to ensure a representative measurement These conditions specified by the manufacturer shall comply with the following values e Exhaled volume greater than or equal to 1 2 L e Pressure greater than or equal to 10 hPa new proposition 20 hPa to be discussed e Flow rate greater than or equal to 0 10 L s 3 2 4 Reference conditions e Ambient temperature 23 C5563 e Relative humidity 50 30 e Atmospheric pressure 1013 20 hPa e Total fraction by volume of hydrocarbons as methane equivalent in the environment lt 2 x 10 mol mol During each test the temperature and the relative humidity shall not vary by more than 5 C and 10 respectively within the reference range 3 3 Maximal permissible errors MPE The following MPE shall apply within the rated operating conditions specified in 3 2 3 3 1 Maximum permissible errors for type approval and initial verification The maximum permissible errors positive or negative on each individual indication are 0 020 mg L or 5 of the true value of mass concentration whichever the greater for all mass concentrations over the measuring range 3 3 2
32. ines Line to earth 2kV AC mains voltage dips short interruptions and voltage variations See OIML D 11 13 4 The mains voltage reductions shall be repeated 10 times with an interval of at least 10 seconds The test conditions are the following Test a Test b Test c Reduction 100 100 30 Duration 0 5 cycle 1 cycle 25 cycles The error of the breath alcohol analyser is determined for each configuration of testing For voltage interruption the test conditions are the following e Interruption gt 95 Duration 250 cycles Electrical transient conduction for external batteries of a vehicle See OIML D 11 14 2 2 This test shall be applied to breath alcohol analyser powered from external 12 V road vehicle batteries If the nominal value for the breath alcohol analyser is 24 V the tests should be done as stated for 24 V in accordance with OIML D11 14 2 2 The test conditions are the following Test pulse 2 Test pulse 3 Test pulse 1 Test pulse 4 2a 2b 3a 3b Level 100 V 50V 10V 150V 100V 1V Minimum number of pulses OF test 5000 pulses 5000 pulses 1 hour 1 pulse time Mechanical shocks See OIML D 11 11 2 e For stationary or and mobile breath alcohol analyser The breath alcohol analyser is placed on a rigid surface in the position in which it is normally used is tilted on one bottom edge and is then allowed to fall freely onto the test s
33. ions that support a determination whether the design of the breath alcohol analyser meets the requirements of this Recommendation The technical documentation shall include a list of the electronic sub assemblies with their essential characteristics a description of the electronic devices with drawings diagrams a description of the software and its characteristics including identification numbers and operation including a list of the data variables and the circumstances when they may be changed mechanical drawings a plan for marking and sealing If the breath alcohol analyser is equipped with a printing device the manufacturer shall provide information about the quality of the printing paper to fulfil the requirements of readability defined in 4 4 Type evaluation consists in assessing the compliance of the breath alcohol analyser with each requirement of this Recommendation 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 15 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers Annex A PERFORMANCE TESTS Mandatory A 1 General This annex defines the program of performance tests intended to verify that the breath alcohol analyser operates as intended in a specified environment and under specified conditions Each test indicates where appropriate the reference conditions for determining the intrinsic error Different kinds of tests apply Test to ensure representative sampling Accuracy t
34. l authority may elect to test to breath differences that are tighter than those listed above The national authority may also elect to not perform a comparison of samples in the event that either of the sample measurements are below the alcohol level that constitutes the offence of driving or working under influence of alcohol Then the analyser shall automatically invalidate the measurement cycle because of breath difference based on national requirements The test procedure for this function consists of measuring two samples of test gases differing by 12 5 in a measurement cycle consisting of two measurements separated by at least two minutes but no longer that 5 minutes The characteristics of the test gases are 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 29 37 August 2007 TC 17 SC 7 Breath Alcohol Analysers e First test gas Test gas No 4 e Second test gas Test gas No 3 e Duration of injection 5 s e Duration of plateau 3 s e Volume 3 L The mass concentration at maximum of an injection curve is 0 40 and 25 mg L respectively with the second gas being lower than the first test gas The results of the sequential test shall be that the instrument will either invalidate the measurement cycle and or display a warning as required by the national authority B 3 Delay before measurement An alternative solution is to ensure that sufficient time has elapsed since the consumption of alcohol to ensure t
35. mply with the requirement specified in 3 7 2 A 5 Influence factors in the parameters which characterise the test gases These tests shall be carried out under a breath profile as defined in A 2 For these tests the values of the parameters that are not specified shall be those defined in the introduction of A 3 The values of the parameters to be varied are specified in A 5 1 to A 5 4 For each test 10 measurements using test gas n 4 shall be performed Each of these 10 measurements shall fulfil the maximum permissible error requirement defined in 3 3 1 To be representative of the human exhalation variation it is necessary to make vary two parameters in the same time volume duration and flow rate are correlated A 5 1 Influence of delivered volume in conjunction with exhalation time e First test e delivered volume 1 2 L 0 1 L e duration ofinjection 4 s 0 5 s e Second test e delivered volume 4 5 L 0 3 L e duration of injection 15 s 0 5 s A 5 2 Influence of the duration of exhalation in conjunction with flow e First test e delivered volume 2 5 L 0 2 L 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 19 37 TC 17 SC 7 Breath Alcohol Analysers A 5 3 A 5 4 A 5 5 e duration of injection 5s 0 5 s e Second test e delivered volume 2 5 L 0 2 L e duration of injection 15 s 0 5 s Influence of the breath profile e First test e delivered volum
36. ng curve of flow rate during a forceful expiry during an humain breath through an EBA flow rate as a fonction of time flow rate L min time of exhalation s Standard to be respected e during the first 1 4 of the time of exhalation the maximum flow rate is reached e at to the 2 3 of the time of exhalation the flow rate of breath must be lower than the 2 3 of the maximum flow rate e starting from the maximum flow rate the flow rate shall significantly decrease without interruption of breath note this standard is sufficiently flexible to allow an easy simulation of a forced exhalation 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 32 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 C 2 MEASUREMENT ALCOHOL DURING EXHALATION DETERMINATION OF THE ALCOHOL PLATEAU The duration of the plate of the alcohol concentration in a human breath shows very variable characteristics according to the morphology of the subjects It is an important influence factor for the determination of the alcohol concentration The object of this chapter is to define a method making it possible to fix characteristics for the determination of over the duration of the alcohol plate at the time of an expiry This chapter relates to mainly the test facilities and relates to the definitions of the breaths of tests Curves of the alcohol concentration as a function of time obtained from a human exhalation Theoretical
37. ntained at the lower value during 9 h Mobile Portable Temperature 55 C 55 C Duration 2 cycles 4 cycles Storage test The error of the breath alcohol Analyser is determined in reference condition prior to the test Then the breath alcohol analyser is powered off and exposed to a low temperature of 25 C during six hours and to a high temperature of 70 C during six hours The change of temperature shall not exceed 1 C min during cooling down and heating up 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 26 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 After a recovery period of one hour the error of the breath alcohol analyser is determined and the default is calculated A 9 Physiological influence quantities The breath alcohol analyser shall be tested according to the following procedure determination of the indication for a dry test gas having an ethanol content of 0 4 mg L 5 without any interfering substance determination of the indication for the same test gas with one and only one of the interfering substances listed in the following table at the indicated mass concentration Interfering substance Nominal value for vapour mass concentration mg L 5 Acetone 0 5 Acetaldehyde 0 15 Methanol 0 1 Isopropanol 0 1 Carbon monoxide 0 2 Toluene 0 2 If the variation of the indication is not more than the maximum val
38. of the mass concentration as indicated below G mg L A 0 4 a Maximum Plateau a Time s tg a na 0 1 mg L s 10 15 The characteristics of the gas injected are the following e delivered volume 3L 0 2L e duration 15s 05s e mass concentration at maximum of the curve 0 4 mg L 0 020 mg L Ten measurements shall be performed and the instrument shall detect the presence of alcohol in the upper respiratory tracts and shall deliver no measurement result B 2 Two measurement cycle B 2 1 First method 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 28 37 TC 17 SC 7 Breath Alcohol Analysers The measuring cycle shall include two measurements These two measurements shall be performed within a delay no smaller than 2 min The breath alcohol analyser shall be able to memorize that constitute the offence of driving or working under influence of alcohol hereafter called the legal value The measuring cycle can be stopped after the first measurement if the concentration value is less than the legal value In that case the result of measurement shall be displayed and printed if applicable If one of the two measurements is less than the legal value and the other one more than or equal to the legal value the smallest result shall be displayed and printed if applicable There is no need of a comparison between the two results If both of the two measurements are mo
39. re than or equal to the legal value it is necessary to calculate the ratio C R C second breath t where t is the time difference between the end of the first breath and the end of the If R is less than 0 03 min the member State may choose one of the two following solutions e the smallest value of C1 and C2 is displayed and printed if applicable e the two values C1 and C2 are displayed and printed if applicable In any case when the second measurement is not performed it is possible to indicate the unique available result as an indicative one for instance indicating measuring cycle not completed If R is more than or equal to 0 03 min the measuring cycle shall be cancelled and the breath alcohol analyser shall display a warning message to specify that the cycle is not valid and that a new one shall start B 2 2 Second method The breath analyser shall use a measuring cycle involving two subject sample measurements each measurement corresponding to an exhalation The two subject sample measurements are separated by at least 2 minutes The resultant displayed or recorded measurement in a subject test is to be specified by the legal authority e g lower value mean of the two values or both values If the difference between the two subject sample measurements exceeds the greater of the following two values e 0 10 mg L or e 20 relative of the smallest of the two measurements Note the nationa
40. st 2007 simulation of curve C f t breath 2 L in 5 s flow rate 0 4 L s dead volume 300 mL plateau reached for a concentration 99 0 after 3 5s 100 00 se 80 00 Q 60 00 5 8 40 00 c 20 00 0 00 0 1 2 3 4 5 Temps s Concentration Proposal for the next draft Confirmation of the mathematical model and qualitative information on the determination of the plateau Example of a curve of alcohol concentration as a function of time obtained on simulation test bench recording of the curve of alcohol concentration expressed in according to time breath 3 L in 5 s dead volume 150 mL plate reached in 2 5 s for 99 5 of alcohol 120 00 100 00 Q z 80 00 2 E 8 60 00 i o 5 40 00 2 oO 20 00 0 00 0 1 2 3 4 5 time of exhalation s 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 36 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 Annexe D Test Report Format To be developed when the list of test is finalised 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 37 37
41. the voltage if applicable when the instrument is powered on at the lower limit of the voltage Stationary Stationary Stationary or AC mains voltage DC mains voltage portable or mobile internal battery Upper limit Nominal voltage 10 Defined by the N A manufacturer Lower limit Nominal voltage 15 Defined by the Limit where the manufacturer instrument ceases to operate within the MPE For breath alcohol analysers powered from external 12 V road vehicle batteries the upper and lower limits are defined hereafter Upper limit 16 V Lower limit limit where the instrument ceases to operate within the MPE AC mains frequency variations See OIML D 11 11 3 This test is applicable to stationary breath alcohol analysers powered by AC mains voltage direct or through a generator Upper limit Nominal frequency 2 Lower limit Nominal frequency 2 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 22 37 TC 17 SC 7 Breath Alcohol Analysers A 6 7 Influence of atmospheric pressure see OIML D11 10 4 e First test Atmospheric pressure 860 hPa 10 hPa e Second test Atmospheric pressure 1060 hPa 10 hPa A 7 Influence of volume fraction of CO e Mass concentration by volume of CO 10 1 A 8 Disturbances tests The tests shall be carried out using test gas n 4 At least 5 measurements shall be performed in each test condition except for t
42. ue defined in 0 1 mg L for the current interfering substances in the above table the breath alcohol analyser has passed the test for the interfering substance concerned If the variation is more than the value defined in and if no error message is given the breath alcohol analyser has failed If an error message is given another test shall be performed with the same interfering substance at a mass concentration 5 times smaller In that case the variation shall not be more than a fifth of the maximum value defined in This test shall be performed at least 5 times for each of the interfering substance Each time the requirement shall be fulfilled National responsible bodies may decide to test the influence of other compounds 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 27 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 Annex B Examples of detection of alcohol in upper respiratory tracts informative The member State may choose one two or all the following solutions for detection of alcohol in the upper respiratory tracts B1 or B2 or avoiding the corresponding influence B3 B 1 Peak method In the event that the breath alcohol analyser mouth alcohol detection operates by the detection of a peak in the IR signal the following test allows demonstrating that the instrument is able to detect alcohol in upper respiratory tracts The test consists in injecting a test gas providing an evolution
43. umidity during the time defined below according to the severity level The error of the breath alcohol analyser is determined one time per day and at the end of the test after a recovery period of one hour Mobile Portable Temperature 30 C 40 C Humidity 85 rel 93 rel Duration 2 days 4 days A 6 4 Random vibrations See OIML D 11 11 1 1 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 21 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 6 5 A 6 6 This test is applicable to mobile and handheld breath alcohol analysers During the test the breath alcohol analyser is powered off The test consists of exposure to the vibration level hereafter defined Total frequency range 10 Hz to 150 Hz e Total RMS level 7 m s ASD level 10 Hz 20 Hz 1 m s e ASD level 20 Hz 150 Hz 3 dB octave The breath alcohol analyser shall in turn be tested in three mutually perpendicular axes mounted on a rigid fixture by its normal mounting means so that the gravitational force actes in the same direction as it would be in normal use The duration of the test shall be a minimum of two minutes per axis The error of the breath alcohol analyser is determined after the whole test has been carried out Power voltage variations See OIML D 11 13 1 13 2 The error of the breath alcohol analyser is determined in the following conditions when the instrument is powered on at the upper limit of
44. urface This test shall be repeated for each edge in turn subject to a maximum inclination of 30 The height of fall given below is that of the opposite edge e For handheld breath alcohol analyser 3rd Committee Draft Recommendation on Breath Alcohol Analysers Page 25 37 TC 17 SC 7 Breath Alcohol Analysers August 2007 A 8 10 A 8 11 A 8 12 3 arbitrary positions are chosen Stationary Mobile Portable Height of fall 25 mm 50 mm lm Number of fall l l 3 Shakes This test simulates shocks in a car trunk The breath alcohol analyser is placed in its reference position on a table which can generate shakes in the following conditions e wave shape half sinusoid e amplitude 10 g g 9 81 m s e duration 6 ms frequency 2 Hz e number of axes 3 perpendicular axes e number of shakes 1000 for each axes Damp heat cyclic condensing OIML D 11 10 2 2 The breath alcohol analyser shall be exposed to cyclic variation between 25 C and the temperature specified below The relative humidity shall be above 95 during the temperature change and low temperature phases and at 93 at the upper temperature phases Condensation should occur on the breath alcohol analyser during the temperature rise The 24 cycle consists of 1 Temperature rise during 3 h 2 Temperature maintained at the upper value during 9 h 3 Temperature lowered to the lower value during 3 h 4 Temperature mai
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