OIML R 126 - Organisation Internationale de Métrologie Légale
Contents
1. 10 32 OIMLR126 1998 E GENERAL EXAMPLE OF AN APPARATUS FOR TESTING EVIDENTIAL BREATH ANALYZERS Informative G 1 General G 1 1 The testing apparatus shall deliver injections of gas corresponding to the specifications of clause 9 and of Annex A An apparatus having components as shown in the diagrams on page 35 should meet the requirement G 1 2 The volume delivered is regulated by the move ment of the actuator The elastic diaphragm correctly simulates the effects of the respiratory muscles and allows the rates of exhalation to be simulated G 1 3 The presence of the dead volume is funda mental rendering possible the production of an injection of gas during which the mass concentration develops in the same exponential manner as in an ex halation By varying the dead volume and the elasticity of the diaphragm the shapes of the curves may be changed G 1 4 According to the technical solutions adopted particularly those associated with the devices to regulate the flow rate the gas analyzer that is included can be considered as a means of checking the ap paratus or as providing a standard if it is calibrated periodically The apparatus may be automated by using any appro priate means 9 From Breath ethanol testing disposable breath tester Part 1 National Testing Information Service USA G 2 Bubbletrain G 2 1 P2. 101 51 39995 3594 1593 JO 3 SJU UILU0O psa 10 psa piepue1s 104 9 qissluuj d 2 21 51591 Enpa any Je UALU Lex 3 ued W UNUUIXE W 104 9 35232919 10119 HAUNN 2 uoneuBis p JSL 29 OIMLR 126 1998 E uonewep 3eeus 3593 Jo 3 uoneiep J04 JOJ JOJI 51591 JO on 92uewo v uoneveq JO 2 ued W 15912949 35912415 JequinN 2 JSL 30 0 IMLR 126 1998 E Concentration of alcohol arbitrary units ANNEX F EVOLUTION OF CONCENTRATION WITH TIME 10 OIMLR 126 1998 E Example of the curve of the flow rate as a function of time as obtained from test rig see 5 1 25 225 1 75 1 5 1 25 0 75 0 5 0 25 max 2 3 L s 10 Example of the curve of the flow rate as a function of time as obtained from a human exhalation 2 5 2 25 1 75 1 5 1 25 0 75 0 5 0 25 max 2 3 L s
3. erari vi 24 OIMLR126 1998 E EXAMINATION REPORT E 6 Reference to OIML R 126 Verified Pass Fail Comments Unit of measurement 4 Measuring range 6 1 Scale interval 6 2 Display 6 3 1 6 3 2 6 3 3 Printing 6 4 Measuring conditions 6 6 1 6 6 2 6 6 3 6 6 4 6 6 5 6 6 6 6 6 7 Safety and security 6 7 1 6 7 2 6 7 3 6 7 4 6 7 5 Put a cross X in the appropriate column s Comments may be developed separately if necessary This Report is continued overleaf 0 126 1998 E EXAMINATION REPORT E 6 Cont d Referenceto OIML R 126 Verified Pass Fail Comments Return to zero 6 8 1 6 8 2 6 8 3 Checking of correct 6 9 1 operation 6 9 2 6 9 3 Adjustment or checking 6 10 1 of correct adjustment 6 10 2 6 10 3 Warm up time 6 11 Duration of indication 6 13 Minimum volume 6 14 Marking 6 15 1 6 15 2 5 15 3 6 15 4 Breath sampling system 6 16 Putacross X in the appropriate column s Comments may be developed separately if necessary 26 OIMLR126 1998 E CONCLUSION OF TESTS E 7 Reference to OIML R 126 Verified Pass Fail Comments result 0 Accuracy 5 11 1 Repeatability 5 2 1 Drift 5 3 1 5 3 2
4. 5 4 1 residual effect 5 4 2 Influence factors volume 1 gas 5 5 1 duration of exhalation D duration of plateau 1 carbon dioxide 1 interruption presence of ethanol Physical AC supply voltage influence factors supply frequency 5 5 2 DC supply voltage ripple on DC voltage temperature humidity pressure hydrocarbons For tests marked with a separate test results sheet is necessary For other tests results may be directly indicated on this document for instance in the following appropriate way errors from to x measurements mean deviation x measurements This Report is continued overleaf OIMLR 126 1998 E CONCLUSION OF TESTS E 7 Cont d Reference to OIML R 126 Verified Pass Fail Comments result 2 Physiological Acetone influence factors Acetaldehyde 5 5 3 M ethanol Annex C Isopropanol Carbon monoxide Toluene Ethyl acetate Methane Diethyl ether Physical D 1 power reduction disturbances D 2 AC parasitic 5 5 4 Annex D D 2 DC parasitic D 3 vibrations 0 4 shocks D 5 electrostatic discharges D 6 electromagnetic fields D 7 magnetic fields D 8 damp heat cyclic D 9 storage conditions D 10 shakes D 11 downpours of water D 11 dust laden atmosphere D 11 salt mist Durability 5 6 28 OIMLR126 1998 E
5. Second example Humid air at 34 C of zero mass concentration CO at I To bellows Insulating Thermostat 34 C sleeve lt Air or N lt Temperature controlled bath Aqueous solution of alcohol renewed periodically 36 OIMLR126 1998 E H TEST SIMULATING THE PRESENCE OF ETHANOL IN THE UPPER RESPIRATORY TRACTS Informative H 1 Evolution of concentration in time C mg L A 0 4 Maximum Plateau a gt Time s tg a 0 1 mgL 1 st 10 15 H 2 Test balloon Test gas Clean air Balloon volume 500 mL OIMLR 126 1998 E ANNEX ADVISABLE PROVISIONS FOR THE MEASURING CYCLE Informative Due to the physiological aspects of measuring ethanol and especially the possibility of ethanol being present in the upper respiratory tracts the legal authority may require that E BAs fulfill the provisions in this Annex Where these provisions are not mandatory the legal authority should provide procedures with the aim of achieving an equivalent level of confidence in the validation of results Provisions are necessarily different for portable and non portable EBAS since by definition a portable EBA is used on the scene without delay and will therefore be more subject to the influence of ethanol in the upper respiratory tracts than a non portable one Although this Recommendation contains a specific test for de
6. OIMLR126 1998 E 6 8 Return to zero 6 8 1 The EBA shall incorporate a device which auto matically zeros or checks the zero of the EBA at least at the beginning of each measurement 6 8 2 The EBA shall be incapable of operation if the return to zero is not accomplished within 0 005 mg L 6 8 3 The action of returning to zero shall include a purge with ethanol free gas ambient air for example The result shall then be indicated 6 9 Checking of correct operation 6 9 1 Checking of correct operation of the EBA comprises in particular checking that all relevant internal elements of the EBA operate correctly checking that the measuring cycle is correctly performed an adjustment checking operation 3 11 6 9 2 EBAS shall check correct operation automatic ally both before each measurement and after any measurement which gives a result greater than a pre determined value of the mass concentration this value may be zero However the legal authority may require the adjust ment checking operation to be performed automatic ally or allow this operation to be performed according to the procedure specified by the manufacturer in the EBAS user manual 6 9 3 When an anomaly a defect or an error signal is detected particularly when correct operation cannot be checked the EBA shall not give a result which may be considered valid and any further measurement shall be prevented until correct operation has bee
7. dead volume to give an exponential evolution of mass concentration during an exhalation 34 OIMLR126 1998 E 94155944 vo gt 94155914 3 3 q gt ga lt gt K 41 3 U 1 pe p X yt LA Jo ne S INA Vd ou OL TEX 4 x x x Y H XD 3 E 3 x 1 O Aug O o gt JezAjeue seo 3 3 J z eue seb piepue1s dundol snonunuoo 3593 ou Jo u33 xs qu lt 3 JO N qu 4 3 c 02 qu lt E Seb Do gt 3 gt Do VE 35 OIMLR 126 1998 E Bubble train First example Humid air at 34 C of zero mass concentration CO p P bellows To waste A Air or N A Insulating Y O9 P2 Thermostat 34 sleeve A lt Temperature lt Aqueous solution of Aqueous solution of Holding flask of controlled bath alcohol renewed alcohol renewed aqueous solution periodically from holding flask of alcohol N B Pumps P1 and P2 havean identical flowrate of approximately 0 33 L h
8. mechanical shocks resulting from normal handling conditions electrostatic discharges electromagnetic fields magnetic fields damp heat cyclic for portable EBAS only ambient storage conditions for portable E BAS only shaking resulting from normal conditions of trans port for portable E BA s only and disturbances for portable E BAs used in the open air only the methods for testing the EBA the values of disturbances and the requirements are given in Annex D 56 Durability After the EBA has been subjected to a durability test as described in 9 6 the errors in the results shall be less than the maximum permissible errors specified in 5 1 2 6 Technical requirements 6 1 Measurement range EBAS shall be capable of measuring all mass concen trations in the range 0 00 mg L to at least 1 50 mg L In normal operation however the EBA may indicate 0 00 mg L for mass concentrations equal to or smaller than 0 05 mg L The greatest permissible value for the upper limit of the measurement range is 3 00 mg L 6 2 Scale interval The scale interval is 0 01 mg L scale interval of the EBAs indication in normal operation During metrological testing or manual calibration it shall be possible to discriminate to 0 001 mg L verif ication scale interval of the EBA 6 3 Display 6 3 1 The result of a measurement shall be displayed digitally by means of aligned figures The display in normal operation shall consist o
9. the influence factors shall remain stable or their variation shall be taken into account particularly in the tests for long term drift in the course of which if the EBA is placed in storage the manufacturer s instructions shall be followed 9 5 Memory and residual effect 9 5 1 Memory effect The EBA shall be subjected 10 times to the following cycle one measurement at a mass concentration of 2 mg L or the upper limit of the measurement range which ever is the smaller one measurement at a mass concentration of 0 40 mg L For the mass concentration at 0 40 mg L the differ ence between the average of at least 10 measurements taken before this test and the average of the 10 meas urements made in the second part of this test cycle shall be less than the value specified in 5 4 1 9 5 2 Small changes in mass concentration A gas with a mass concentration of 0 40 mg L shall be injected at least 10 times in succession after which a gas with a mass concentration of 0 30 mg L shall be injected a maximum of 5 times Therequirement in 5 4 2 shall be fulfilled 9 6 Durability test Test procedure 1 The EBA having satisfied all the other pattern approval tests shall be placed in a chamber for 8h in the stand by mode In the test chamber the temp erature shall be 40 C and the relative humidity 90 96 2 Then with the 5 power turned off the temp erature of the chamber shall be raised to 60 C for lh 3
10. Semi automatic adjustment on command by the user as required by the manu facturer in the user manual 9 1 7 The tests specified in this Recommendation constitute an example of a basic test procedure If uncertainty exists as to the extent to which an EBA conforms to the requirements given in this Recom mendation other values of the test parameters may be chosen 9 1 8 Without prejudice to the above provisions and provided that they do not significantly influence the measurement results the parameters that characterize the test means may be different from those specified in this Recommendation This allows the use of simpli fied test means for some tests that for example imply transportation of these test means mainly tests in Annexes B and D Such means may consist in dry gases in containers or preferably wet gases generated by simple test means e g the absence of CO in test gases constant mass concentration during injection The laboratory test reports shall indicate when such alternative test means have been implemented Moreover the fact must be taken into consideration that for some of the requirements the errors must fall within the range of maximum permissible errors whereas other requirements specify that a deviation between two values must fall within a maximum permissible deviation For example when results that are provided by a simplified test means are used with and without the effect of an influence facto
11. When the temperature has stabilized at ambient temperature the EBA is subjected to a sweep of frequencies of sinusoidal vibrations under the following conditions range of frequencies 10 Hz 150 Hz rms acceleration 10 m s for portable 5 and 5 m s for non portable ones sweep on three perpendicular axes rate of sweep one octave per minute number of sweep cycles up and down non portable EBA 5 on each axis portable EBA 20 on each axis 4 Finally the EBA shall be returned to the chamber in its stand by mode and subjected to rapid variations of temperature between 0 C 40 C for 16 h Condensation on the EBA shall be avoided This operation may be performed in the following manner raise the temperature to 40 C reducethe relative humidity to less than 30 96 change from one temperature level to the other every hour ensuring that the ambient temperature changes from one level to the other in approx imately 15 minutes 5 After the test at least 5 measurements are per formed OIMLR 126 1998 E ANNEX A INFLUENCE OF VARIATIONS OF THE PARAMETERS WHICH CHARACTERIZE THE TEST GASES Mandatory For these tests the values of the parameters that are not specified shall be those in 9 2 The values of the parameters to be varied are specified in A 1 to A 6 Ten measurements shall be made for each test using test gas No 4 Influence of delivered volume First test delivered volume 1 5
12. a solution of ethanol in water whose ethanol mass concentration is equal to 1 8 g L The volume of the solution is 250 mL and its temperature is 34 C Annex H shows a scheme of such a device 14 OIMLR126 1998 E PHYSICAL INFLUENCE FACTORS Mandatory 1 Test conditions The effect of each influence factor shall be determined separately and influence factors not under investiga tion shall remain at their reference values as specified in B 2 The effects of the various influence factors shall not be combined The test shall be carried out using test gas No 4 At least 5 measurements should be made in each test condition When applicable the tests shall be carried out in accordance with IEC Publication 68 2 1 cold 68 2 2 dry heat B 2 Reference conditions and rated operating conditions The reference conditions and the extreme values of the rated operating conditions for the physical influence factors that are taken into account in the tests are given in Table 1 see page 16 B 3 Requirements The errors in the results obtained at reference and rated operating conditions shall not exceed the max imum permissible errors stated in 5 1 1 In the test at the extreme value of hydrocarbons in the environment however the E BA is permitted to give no result Battery powered E BAs shall have a means to indicate when the voltage falls below a value specified by the manufacturer OIM
13. ethanol content of 0 4 mg L 5 without any interfering substance 2 Determination of the indication for the same test gas with one and only one of the interfering substances listed in Table 2 at a mass concentra tion also indicated in Table 2 with the indicated tolerance on nominal value 3 If the variation of indication is not more than the maximum influence indicated below the EBA has passed the test for the interfering substance con cerned if the variation is more than the maximum influence and if no signal is given the EBA has failed if a signal is given another test shall be made with the same interfering substance at a mass concentration 5 times smaller the variation shall not be more than a fifth of the maximum in fluence 4 This test shall be performed at least 5 times for each of the interfering substances listed in Table 2 Note National authorities may decide to test the influence of other compounds Table2 Interfering substances Nominal value for vapor Interfering mass concentration Maximum influence substance mg L 5 mg L Acetone 0 5 0 1 Acetaldehyde 0 15 0 1 Methanol 0 1 0 1 Isopropanol 0 1 0 1 Carbon monoxide 0 2 0 1 Toluene 0 2 0 1 Ethyl acetate 0 15 0 1 Methane 0 3 0 1 Diethyl ether 0 3 0 1 OIMLR 126 1998 E ANNEX D PHYSICAL DISTURBANCES Mandatory Tests shall be performed with a single gas which shall normally be test gas No 4 At least 5 mea
14. format the results of the various tests and examinations to which a pattern of an evidential breath analyzer EBA shall be submitted with a view to its approval All metrology services or laboratories evaluating patterns of EBAS according to OIML R 126 to national or regional regulations based on OIML R 126 are strongly advised to use this Test report format directly or after translation into a language other than English or French Its direct use in English or in French or in both languages is even more strongly recommended whenever test results may be trans mitted by the country performing these tests to the approving authorities of another country under bi or multi lateral cooperation agreements In the frame work of the OIML Certificate System for Measuring Instruments use of the Test report format is man datory 22 OIMLR126 1998 E Report No OIML Recommendation No Edition 1 Name and address of the testing laboratory ies E 5 Identification of the pattern tested Tradename Model gu aspa Serial Brief description if useful including reference to diagrams and inscriptions OIMLR 126 1998 E E 6 Vi
15. national responsible body shall carry out the following performance tests or where applicable may accept the manufacturer s test data to verify that the EBA fulfills the requirements in clause 5 i e accuracy test maximum permissible errors 5 1 1 and 9 3 repeatability test 5 2 and 9 3 drift test 5 3 and 9 4 memory effect test 5 4 and 9 5 influence quantities tests 5 5 and Annexes A B C D and H durability test 5 1 2 5 6 and 9 6 8 1 4 For each test the expanded uncertainty calculated with k 2 of the composition of the test gases shall be less than one fourth of the applicable mpe 8 1 5 The report on the examination and the tests of the EBA carried out at pattern evaluation shall contain as a minimum the items of information according to the format provided in Annex E A specific form may be developed according to national preference However use of this Test Report Format is mandatory in the framework of the OIML Certificate System The manufacturer shall be provided with specific comments about any test failures 8 2 Initial verification 8 2 1 All requirements in this Recommendation may be subject to testing particularly when they are critical to the specific application 8 2 2 It is recommended however that E BAS be tested systematically to verify the following accuracy 9 3 1 and 5 5 1 repeatability 9 3 1 and 5 2 effect of the volume delivered A 1 effect of the du
16. of the instrument serial number measurement range range of ambient temperature in which the EBA may be used warm up time if the requirement in 6 11 is not fulfilled length of time or the number of analyses permitted between maintenance operations including adjust ment in accordance with 3 9 described in the user manual supplied by the manufacturer All of this information shall be legible and grouped together on a visible part of the EBA 6 15 2 Verification marks may be applied by means of a stamp It is however recommended that national regulations provide for the replacement of these marks by a sticker attesting to the regulatory status of the EBA 6 15 3 Although the EBA is designed to detect the presence of ethanol in the mouth it is strongly re commended that an inscription analogous to that in 5 5 1 c be marked on the even if it fulfills the corresponding requirement However it may be suffi cient to includethis information in the user manual 6 15 4 Instruments which use specific technology may berequired to bear particular marking 6 16 Breath sampling system The EBA breath sampling system including the mouthpiece shall not allow the subject of the measure ment to inhale contaminated air from previous usages It shall prevent the deposition of droplets from exhaled breath in the EBA 7 Practical instructions If the national regulation prescribes a metrological logbook this shall be presen
17. variations of atmospheric pressure and variations of the compressibility factor between filling and usage conditions are taken into account the quality of the containers should be taken into account to minimize contamination and a change in composition of ethanol throughout its use cycle test reports shall indicate when dry gases were used and how their equivalence with moist gases was established 9 3 Maximum permissible errors and repeatability 9 3 1 Compliance with maximum permissible errors and repeatability requirements should be verified at least at the following nominal scale values 12 OIMLR126 1998 E Test gas Mass concentration No mg L 1 0 00 to 0 05 0 15 0 25 0 40 0 70 0 95 1 50 upper value if appropriate O UI 9 3 2 For pattern evaluation at least 20 measurements should be made with each gas At each mass con centration the measurements shall be made consec utively 94 Drift 9 4 1 At least 10 measurements shall be made with each of test gases Nos 1 and 4 respectively to verify compliance with 5 3 Then 10 further measurements are made using the same gases after the intervals specified in 5 3 2 Other tests provided for in this Recommendation for pattern evaluation may be performed during the drift test 9 4 2 For each gas the deviation between the mean values of the two series of measurements shall fulfill the requirements in 5 3 2 9 4 3 During the drift tests
18. C during 3 h temperature maintained at 25 C during 9 h ZT o Additional information number of cycles 2 power during cycles off e duration of recovery 1h recovery temperature 20 Requirement After the test measurement errors shall not exceed the maximum permissible errors D 9 Storage ambient conditions for portable only Test method The EBA is placed in a thermal room at temperatures and for durations as indicated below The power is off Test conditions a Cold temperature 25 C duration 2h b Dry heat e temperature 70 C e duration 6h Requirement After these two test conditions and recovery for 1h measurement errors shall not exceed the maximum permissible errors D 10 Shakes for portable E BA s only This test simulates shocks in a car trunk The EBA is placed in its reference position on a table that can generate shakes in the following conditions 20 OIMLR126 1998 E wave shape half sinusoid amplitude 10 g g 9 81 m s duration 6 ms frequency 2 Hz number of axes 3 perpendicular axes number of shakes 1000 for each axis 0 11 Additional tests for portable E BA s used in open air downpours of water or rain water dust laden atmosphere salt mist Under consideration OIMLR 126 1998 E ANNEX E TEST REPORT FORMAT Introduction The Test report format aims at presenting in a standardized
19. L Second test delivered volume 4 5 L with condition of A 2 for duration A 2 Influence of duration of exhalation Total duration of each injection 15 s Duration of plateau 6 s Influence of duration of plateau Duration of plateau 1 5 s 4 Influence of mass concentration of carbon dioxide Mass concentration by volume of 10 A Influence of interruption in the flow of breath First test the injection of gas normally required for the reference conditions specified in 9 2 shall be stopped 1 s after the start of injection Second test the injection of gas normally required to last 15 s see A 2 shall be stopped 6 s after the start of injection A 6 Test simulating the presence of ethanol in the upper respiratory tracts The test consists in injecting a test gas providing an evolution of the mass concentration in ethanol as indicated in Annex H The scheme shows that the curve has a maximum and a plateau Between this maximum and this plateau the slope of the curve has a maximum value which is the main characteristic of the test This maximum value of the slope shall be equal to 0 1 1s with a relative tolerance of 10 96 The other characteristics of the test gas are volume 3L duration 155 mass concentration at maximum 0 4 mg L of the curve Such a test gas can be obtained by blowing clean air through a balloon flask having a volume equal to 500 mL The balloon contains
20. L and less than or equal to 2 000 mg L 3096 of the measured concentration for all mass concentrations greater than 2 000 mg L 5 1 3 Rounding When comparing the error of an EBA with the cor responding maximum permissible error this mpe shall OIMLR 126 1998 E be rounded to the value of the verification scale inter val The error of a reading indicated by an EBA may be greater than the mpe by one verification scale interval 5 2 Repeatability 5 2 1 Estimation of the standard deviation An estimate of the standard deviation is given by the formula where n the number of measurements made at a given mass concentration Y the ith indication out of n of the EBA for that mass concentration Y the arithmetic mean of then values 5 2 2 Requirements The standard deviation for all mass concentrations less than 0 400 mg L shall beless than 0 007 mg L The relative standard deviation for all mass concentra tions greater than or equal to 0 400 mg L and less than or equal to 2 000 mg L shall be less than 1 75 96 The relative standard deviation for all mass concen trations greater than 2 000 mg L shall be less than 6 96 5 2 3 Probability of compliance The statistical probability that the EBA satisfies the requirements of 5 2 2 shall be no less than 95 96 for each mass concentration For 20 measurements for example this provision would lead to EBAS being refused with an estimation of th
21. LR 126 1998 E Table 1 Reference and rated operating conditions Influence factor Reference conditions Extreme values AC supply voltage Nominal voltage NV 15 of NV PPS j j 10 of NV Supply frequency Nominal frequency NF 2 of NF 00 DC supply voltage Nominal voltage NV 24 96 of NV 9 Ripple on DC voltage frequency range 40 Hz 400 Hz id pisi pork 15 C and 35 C for non portable E BAS b Ambient temperature 19 C 22 0 C and 40 C for portable E BAs P Ambient relative humidity RH Ambient RH of thelaboratory 30 90 Ambient AP 20 kPa in the environment Atmospheric pressure AP Ambient AP Ambient AP 4 kPa Total fraction by volume of hydro carbons as methane equivalent 2 106 5 10 6 Notes to Table 1 f the EBA gives results when the voltage is outside this range of values they shall be correct Under voltages may occur at any time before or during the measuring cycle with durations ranging from 2 s to that of the cycle b f the manufacturer indicates extreme ambient conditions which are more severe than these values the tests shall be performed at the values given by the manufacturer 16 OIMLR126 1998 E PHYSIOLOGICAL INFLUENCE FACTORS Mandatory EBAS shall be tested according to the following pro cedure 1 Determination of the indication for a dry test gas having an
22. OIML R 126 Edition 1998 E INTERNATIONAL OIMLR 126 RECOMMENDATION Edition 1998 E Evidential breath analyzers Ethylom tres ORGANISATION INTERNATIONALE DE METROLOGIE LEGALE INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY OIMLR 126 1998 E Contents FOreWO a yaaa a qayana de 3 1 SCOPG 4 2 ADDIICAIONS 4 4 Units ot measurement m u cnr eren cre nnn HR e FR umanku qaqa usai RS 5 5 Metrological F quirements a a q m hun 5 6 Technical Tequitements opo dri rea foe an dao Eno dr E ab Fu 7 T Practicallnstt ctloris asa cem mm a 10 8 Metrological controls 10 Edu LE 11 AnnexA Influence of variations of the parameters which characterize the test gases n 14 AnnexB Physical influence factors asini ero iti ped aro tni c retra FG Hor e e n ER a c 15 AnnexC X Physiological influence factors nnne nnne nnt nennen nennen tirer 17 Anne D Physical diStulDaliCeS uu terit dre Dort 18 AnnecE cse ore rane bo oerte pe REDE ES 22 AnnexF Evolution of concentration with time _ L I I nn 3l AnnexG General examp
23. allest measurement result shall be displayed Where AP is greater than 15 gl min then one supplementary measurement shall be required by the EBA to be performed within 5 to 10 minutes after the previous one Operation d above is repeated until AP is less than or equal to 15 ugL 1min in which case the small est measurement result shall be displayed 1 2 3 The EBA shall check that the above delays respected If this is not the case it shall stop the measuring cycle For delays for which a tolerance is not already given the tolerance shall be between 0 and 2 minutes only in positive value b C d 1 2 4 If allows measurements for other subjects to be started before the result s relevant to previous subjects have been displayed any possibility of confusion of results shall be prevented 1 3 Provisions applicable to both types of EBA 1 3 1 For legal metrology purposes the EBA shall be capable of providing the result after each measure ment when performing metrological tests 1 3 2 Each measurement of the cycle shall always at least include verification of zero adjustment and if necessary zero adjustment before each measurement in conformity with 6 8 verification of correct operation of the EBA in con formity with 6 9 1 3 3 Where it is not possible to complete the meas uring cycle as defined in 1 1 or 1 2 it shall be possible to obtain the previous measur
24. anual 6 12 Measuring cycle National authorities shall define what constitutes a measuring cycle i e the set of operations which may permit the operator to conclude whether or not a person is under the effect of alcohol A measuring cycle may be defined in terms of number of successive individual measurements sequence for displaying the results consideration of variations between results particu larly in relation with the effect of alcohol in the upper respiratory tract etc Advisable provisions are given in Annex 6 13 Length of time during which the result is indicated It shall be possibleto retain the results in a readable or accessible form for at least 15 minutes If this require ment can be met only by printing the results the OIMLR 126 1998 E absence of paper in the printer shall prevent measure ments being made Note The initiation of a new measurement cycle may shorten this period 614 Minimum volume For 5 that do not monitor maximum mass con centration during exhalation measurements shall imply an exhalation volume equal to at least 1 5 L This shall particularly apply to EBAs that perform a measurement after a preset volume or period of time for exhaling 6 15 Markings 6 15 1 An EBA shall be marked indelibly and irremov ably with the following information pattern approval mark after a successful evaluation of the pattern manufacturer s name denomination
25. atory tract the national authorities may either decide that the instrument give no result or else establish provisions concerning the use of the OIMLR126 1998 E for example label stating Wait at least minutes if the subject has drunk alcohol recently 5 5 2 Physical influence factors Concerning the following physical influence factors AC supply voltage supply frequency DC supply voltage ripple on DC voltage ambient temperature ambient relative humidity atmospheric pressure and quantity of hydrocarbons in the environment the methods for testing the EBA the values of factors and the requirements are given in Annex B 5 5 3 Physiological influence factors Constituent parts of medicines or the products of ab normal human metabolic substances contained in solvents or industrial products or other gases may influence the result of the measurement if present in the breath Annex C gives the list of interfering substances with nominal values and maximum influences with which EBAS shall be tested in order to verify that they meet the requirements of this Recommendation concerning physiological influence factors 5 5 4 Physical disturbances Concerning the following physical disturbances short time power reduction parasitic voltages on the mains vibrations resulting from normal conditions of transport or those corresponding to a stationary vehicle with the engine idling
26. e disturbances shall differ by no more than the absolute value of the mpe or the EBA shall not give a result D 6 Electromagnetic field see also IEC 801 3 Results obtained respectively with and without dis turbances shall not differ by more than the absolute value of the mpe when the EBA is exposed to electro magnetic fields of Frequency range 26 MHz 1000 MHz Field intensity 10 V m Modulation amplitude 80 1 kHz sinewave See also note to D 7 D 7 Magnetic field The EBA shall be placed in a magnetic field of 50 Hz or 60 Hz and an intensity of 60 A m such as may be produced by a square coil of 50 turns of side 1 m carrying a current of 1 A The results obtained respect ively with and without the disturbance shall not differ by more than the absolute value of the mpe Note For the tests D 6 and D 7 the fields may be applied at any time before or during the meas uring cycle It is permissible for the EBA not to give result D 8 Damp heat cyclic for portable only Test method The EBA shall be exposed to cyclic temperature vari ation between 25 C and 55 C The relative humidity shall be above 95 96 during the temperature change and at 25 C and shall be at 93 96 at 55 C Condensation should occur on the EBA during the temperature rise The 24 h cycle consists of 1 2 3 4 temperature rise during 3 h temperature maintained at 55 C during 9 h temperature lowered to 25
27. e influence of alcohol but are used as detectors of alcohol in the breath 3 Terminology 3 1 Evidential breath analyzer An instrument which measures the mass concentra tion of ethanol by analyzing deep lung air usable for evidential purposes 3 2 Non portable evidential breath analyzer An EBA intended only for use within buildings or places providing similar environmental conditions Note The use of non portable E BAs in mobile labo ratories may be considered providing adapted conditions of transport are assured 3 3 Portable evidential breath analyzer An EBA that may be used within or outside a building 3 4 Deep lung air Breath delivered from the mouth of a subject that originates from the alveoli of the lungs normally referred to as end expiratory breath 3 5 Alveolar air Air contained in the pulmonary alveoli 3 6 Normal operation The mode of usage which corresponds to the program of operations specified for E BAS in service 3 7 Stand by mode The mode of the EBA in 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 OIMLR126 1998 E 3 8 Measuring mode The clearly marked mode in which the EBA can make measurements at the rate normally expected in service and in which it shall meet the performance require ments of this Recomme
28. e standard deviation greater than 1 26 times the maximum permissible standard deviation 53 Drift 5 3 1 Zero drift The zero drift shall be less than 0 010 mg L in 4h 5 3 2 Drift at 0 40 mg L 5 3 2 1 Short term drift The drift at 0 40 mg L shall be less than 0 010 mg L in 4 h 5 3 2 2 Long term drift The drift at 0 40 mg L shall be less than 0 020 mg L in 2 months 5 4 Memory and residual effect 5 4 1 Memory effect The memory effect shall be less than 4 96 in relative value when the test is conducted according to 9 5 1 5 4 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 the maximum permissible error for the lower mass concentration 5 5 Influence quantities When tested the EBA shall meet the requirements with regard to the following influence quantities 5 5 1 Influence factors in the parameters which characterize the test gases The test methods and factor values are given in Annex A a Concerning the influence of delivered volume duration of exhalation duration of plateau and carbon dioxide the errors in the results shall not exceed the maximum permissible errors stated in 5 1 1 b Concerning the influence of interruption in the flow of breath the EBA shall not give a result c Concerning the influence of ethanol in the upper respir
29. ement result s upon special command after a specific period of time In this case the EBA shall indicate that the measure ment cycle has not been completed 1 3 4 In normal operation if the EBA detects a fault in the course of an exhalation interruption disturbance etc only this exhalation shall be invalidated except if the EBA detects the presence of ethanol in the upper respiratory tracts or the presence of a physiological influence factor in which cases all the measuring cycles shall be invalidated 1 3 5 The reproducibility of the EBA taking into account the variations of the parameters considered in A 1 A 2 and shall be consistent with the necessity to monitor the variations in the results considered in 1 2 Printed in France GRANDE IMPRIMERIE DE TROYES 130 rue G n ral de Gaulle 10000 Troyes
30. ethod 9 1 General 9 1 1 The apparatus used by the laboratory for testing the EBA shall deliver test gases having mass concen trations of ethanol analogous to those which evolve during an exhalation This evolution is characterized by a plateau in the curve of mass concentration against time during the last part of the injection the duration of which is fixed for each test 9 1 2 The mass concentration at the plateau shall be considered to be the true value of the test mass con centration 9 1 3 Annex F shows the general form of this evo lution of mass concentration as well as that of the evolution of flow rate during a test Annex G gives an example of a design of a testing apparatus capable of generating the required evolutions of mass concentra tion and flow rate Other apparatus that can provide equivalent performance may be used OIMLR 126 1998 E 9 1 4 Taking into account the capabilities of the testing apparatus the tests shall be conducted with the maximum frequency allowed by the EBA according to 6 6 5 9 1 5 With the exception of the study of the influence of physical influence factors see Annex B and where appropriate of the study of drift tests shall be per formed under the reference conditions specified in B 2 9 1 6 The EBA may be adjusted manually if necessary before testing starts Thereafter no adjustment shall be made until all testing is finished This does not apply to self calibration
31. exposed to random vibrations in the following conditions tis mounted so that the gravitational force acts in the same direction as it would in normal use The power is off Total frequency range 10 Hz 150 Hz Total RMS level 10 m s Acceleration spectral density from 10 Hz to 20 Hz 2 112 53 from 20 Hz to 150 Hz 3 dB octave Number of axes 3 perpendicular axes Duration per axis lh Requirement After the test measurement errors shall not exceed the maximum permissible errors 0 4 Mechanical shock Test method The EBA 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 surface The height of fall given below is that of the opposite edge 25 mm for non portable E BAs 50 mm for portable E BAs The test shall be repeated using each of the lower edges Requirement After the test measurement errors shall not exceed the maximum permissible errors D 5 Electrostatic discharge Test method see also EC 801 2 The EBA shall be subjected randomly during the measuring cycle to electrostatic discharges of 8 kV for OIMLR 126 1998 E air discharges and of 6 kV for contact discharges from a capacitance of 150 pF discharging through a resist ance of 330 Q with an interval between discharges of at least 10 s Requirement The results of measurements made with and without th
32. f display or printing National authorities may prohibit the display or print ing of results which do not represent the final meas urement result 6 6 Measuring conditions 6 6 1 The EBA shall be designed to ensure that meas urements are made on samples of deep lung air 6 6 2 When the measurement result is nil it shall not be possible to confuse such a result with the zero indication prior to measurement This requirement is deemed to be satisfied if for example the EBA in dicates the various phases of the measuring cycle 6 6 3 The EBA shall monitor the continuity of exhala tion and shall give an indication if the flow of exhaled air ceases momentarily or completely between the beginning of the exhalation and the end of the taking of a sample thus allowing a valid result to be ob tained A warning signal preferably audible shall enable the determination of continuity of exhalation The exhalation shall be considered interrupted if the flow is below 0 1 L s 6 6 4 The exhalation pressure necessary to obtain a sample of exhaled air with the mouthpiece fitted shall not exceed 25 hPa at a flowrate of 0 17 L s 6 6 5 The EBA shall indicate it is ready to make a measurement and shall prohibit measurement when it is not ready these two functions shall be compatible 6 6 6 After successful checking of correct operation according to 6 9 2 and from the moment it indicates that it is ready to receive an exhalation the EBA
33. f the display in metro logical testing to 0 001 mg L rounded down to 0 01 mg L eg a measured value of 0 427 mg L shall be displayed as 0 42 mg L in normal operation 6 3 2 The height of the figures shall be equal to at least 5 mm for fluorescent registering devices or devices having a luminosity recognized as equivalent 10mm in all other cases 6 3 3 The name of the unit of measurement or its symbol shall appear in close proximity to the figures indicating the result and the characters used shall be at least 3 mm in height OIMLR 126 1998 E 6 4 Printing device EBAS may be equipped with printing devices which print the result of the measurement In normal operation the printed result shall not differ from that which is indicated by any other indicating device s the symbol of the unit in which the result is ex pressed If the symbol of the unit is preprinted the paper shall be specially prepared for the printing device Printouts shall remain readable for one month even when exposed to daylight or equivalent lighting The printing device should include a means to check that characters are correctly printed The legal authority may require that a printing device be provided It may also require that more information appear on the printed document than requested above and that measurements are not possible if paper or other medium is not available in the printing device 6 5 Prohibition o
34. iding contradictory requirements consequently manu facturers and users of measuring instruments test labo ratories etc may apply simultaneously OIML publications and those of other institutions International Recommendations and International Docu ments are published in French F and English E and are subject to periodic revision This publication reference OIML R 126 edition 1998 E was developed by the OIML subcommittee TC 17 SC 7 Breath Testers It was approved for final publication by the International Committee of Legal Metrology in 1997 and will be submitted to the International Conference of L egal Metrology in 2000 for formal sanction OIML publications may be obtained from the Organization s headquarters Bureau International de M amp rologie L gale 11 rue Turgot 75009 Paris France Telephone 33 0 1 48 78 12 82 and 42 85 27 11 Fax 33 0 1 42 82 17 27 E mail biml iml org OIMLR 126 1998 E Evidential breath analyzers 1 Scope 1 1 This International Recommendation applies to evidential breath analyzers hereafter referred to as EBAS which are instruments that automatically measure the mass concentration of alcohol in exhaled breath However for the purpose of this Recommendation only ethanol is considered as alcohol In fact physiological phenomena associated with alcohol and in particular the definition of that which constitutes the offence of driving or working etc unde
35. in ISO 7637 1 or 2 Test level or 20 Pulses are applied continuously during the meas uring cycle Switching processes pulses 3 a and b in ISO 7637 1 or 2 Test level or 20 Pulses are applied before and during the measuring cycle Requirement The results of measurements obtained with and with out the disturbances specified in D 2 shall not differ by more than the absolute value of the mpe or the EBA shall not give a result when subject to disturbances D 3 Vibration a General Test method see also I EC 68 2 6 The EBA shall be subjected to vibration on three axes in a swept range of frequencies of 10 Hz 150 Hz with an rms acceleration of 2 m s If resonance is observed 5 measurements shall be made at each of the resonant frequencies If no resonance is observed 10 measure ments shall be made at 50 Hz or 60 Hz This test may require the removal of the casing Requirement With portable EBAS the errors in the results of meas urement shall not exceed the maximum permissible errors The normal test level is 3 However the EBA may be approved if it only fulfills level 2 In this case a mention is indicated in the pattern approval certificate With non portable EBAS the results obtained with and without disturbances shall not differ by more than the absolute value of the mpe or the EBA shall not give a result b Random vibrations for portable E BAS only Test method The EBA is
36. ive a result D 2 Parasitic voltages and disturbances on the mains 1 Test method for alternating current supply see also IEC 801 4 The disturbances shall be applied during the meas uring cycle Transient voltages of each polarity shall be applied to the supply randomly phased The over voltages shall be generated in common mode or in differ ential mode The amplitude rise time duration and rate of re petition are specified in Table 3 2 Test method for direct current supply EBAS that may be supplied from a source of direct current that is not dedicated to their exclusive use for example EBAS drawing power from the battery of a vehicle shall be submitted to the following tests Table3 Disturbances on the mains Amplitude on Induced Rise time Duration to Rate of the supply amplitude half amplitude repetition 2000 V 1000 V 5ns 50 ns single shot 3 nguctive coupling on the control wires and data wires of the entry and exit cables between the EBA and any peripheral device 18 OIMLR126 1998 E Disconnection of inductive loads from the supply pulse Lin ISO 7637 1 or 2 Test level or 20 The pulse is applied during the measuring cycle and repeated every 5 s However in the case of pulse b in ISO 7637 2 the disturbance is confined to a single pulsein the course of each measurement of the measuring cycle Interruption of the vehicles circuit pulse 2
37. le of an apparatus for testing evidential breath analyzers sse 33 AnnexH Test simulating the presence of ethanol in the upper respiratory tracts een 37 6850100 38 OIMLR126 1998 E Foreword OIML is a worldwide intergovernmental organization whose primary aim is to harmonize the regulations and metrological controls applied by the national metro logical services or related organizations of its Member States T International Organization of Legal Metrology The two main categories of OIML publications International Recommendations OIML R which are model regulations that establish the metrological charac teristics required of certain measuring instruments and which specify methods and equipment for checking their conformity the OIML M ember States shall implement these Recommendations to the greatest possible extent International Documents OI ML D which are inform ative in nature and intended to improve the work of the metrological services OIML Draft Recommendations and Documents are de veloped by technical committees or subcommittees which are formed by the M ember States Certain international and regional institutions also participate on a consultation basis Cooperative agreements are established between OIML and certain institutions such as ISO and IEC with the objective of avo
38. n checked 6 10 Adjustment or checking of correct adjustment 6 10 1 For purposes of maintenance and legal metro logical control it must be possible to adjust or check correct adjustment of the EBA using the standard mixture of gases under the conditions specified in 3 9 This standard mixture of gases may be contained within the EBA 6 10 2 should in principle be adjusted to a standard 3 9 or adjusted by simulation 3 10 or checked to be correctly adjusted at a scale value between 0 25 mg L and 0 50 mg L A different value however may be chosen when it has been demon strated that such a value gives at least the same accuracy in that part of the scale 6 10 3 When the automatic adjustment device s no longer allow s adjustment or when the automatic checking of correct adjustment no longer gives a confirmatory result the EBA shall no longer be capable of making measurements 6 10 4 The legal authority may require routine ad justments or routine checks of correct adjustment involving a given means for instance dry gas in a pressure vessel or humid gas delivered by a simulator 6 11 Warm up time Under reference conditions the EBA shall be capable of attaining the measuring mode 15 minutes after being switched on 5 minutes after a switch from stand by mode to measuring mode However if these requirements are not fulfilled the corresponding times shall be marked on the EBA and provided in the user m
39. ndation Note The measuring mode and the stand by mode 3 7 are modes of normal operation 3 6 3 9 Device for adjustment to a standard A device for adjusting the EBA using as a standard a mixture of gases having a relative humidity of at least 90 96 and a temperature of 34 1 The mixture of air and ethanol passes through the entire gas analysis train starting with the mouthpiece in the direction normally taken by exhaled air Note Adjustment using a dry gas is possible provided that the difference of effect between wet and dry gases is known or can be automatically cor rected 3 10 Device for adjustment by simulation A device for adjusting the EBA by a procedure other than that specified in 3 9 notably by the simulation of the effects of the passage of a standard mixture of gases as described in 3 9 3 14 Adjustment checking operation An operation involving all relevant internal elements which verifies that the EBA is suitably adjusted 3 12 Drift The change in the indication which occurs during a stated period of time at a given mass concentration of ethanol in air 3 13 Memory residual effect The difference between the indications obtained with two inputs of gas of a given mass concentration a gas of a specified higher mass concentration being in jected between these two inputs This 1 C tolerance does not correspond to the uncertainty when preparing calibration gases which is usuall
40. r the error which has been found under reference conditions shall be taken into account before comparing the effective error to the maximum permissible errors The effective error e can be considered as 1 11 teg where theindication with an influence factor and with simplified test means indication without an influence factor and with simplified test means the error of the EBA under reference conditions with the test means described in this Recom mendation 9 2 Characteristic reference values of the test gas Unless otherwise specified the test gas shall be char acterized by the following parametric values delivered volume 3L total duration of injection into breath analyzer 5 s duration of plateau of mass concentration when injecting into the EBA 3 s carrier gas pure air gas temperature 34 C 0 5 relati ve humidity of gas at least 95 96 volumetric fraction of CO 5 1 injected continuously and with increasing mass con centration of ethanol Note Other gases may be used provided that their influence on test results can be taken into con sideration and corrected for however influences which do not exceed a quarter of the applicable mpe do not need to be corrected for for dry gases it is verified that the EBA is capable of measuring moist gases risk of pollution of the hydraulic circuit by water for cases involving dry gases in containers
41. r the influence of alcohol are not within the scope of this Recommendation Likewise the legal definition of which compounds methanol ethanol propanol etc constitute alcohol is not provided in this Recom mendation such considerations being established by the responsible authorities of each country 1 2 This Recommendation does not apply to screening devices which only detect ethanol without providing a sufficiently accurate measurement see 2 2 1 3 The performance requirements given here apply to EBAS using currently available technology This is not intended to restrict technical development nor exclude the use of other technologies as a means for analysis 1 4 National authorities may require EBAS to include a specific conversion device that converts the measure ment result obtained in terms of ethanol content in the exhaled breath at the measuring conditions either into physiological conditions or in terms of other quant ities This Recommendation does not cover the metro logical performance of such devices 1 5 The purpose of this Recommendation is to define the performance requirements of EBAs and the means and methods employed in testing them 2 Applications 2 1 EBAS can be used to measure accurately and display numerically the breath alcohol mass concen tration of persons drivers workers etc who may have consumed alcohol 2 2 Screening devices are not generally used for establishing proof of driving under th
42. ration of exhalation A 2 effect of the duration of the plateau A 3 8 2 3 The number of test gases or the number of measurements may be reduced in relation to those specified in this Recommendation 8 2 4 The period of validity of this verification shall be specified by the national responsible body 9 Refer to the Guideto the expression of uncertainty in measurement 1995 edition 8 3 Periodic verification 8 3 1 Periodic verification may be confined to verifica tion of accuracy 9 3 1 and 5 1 1 or 5 1 2 according to the national responsible body for various conditions of injection 9 2 A 1 A 2 and A 3 8 3 2 The number of test gases or the number of measurements may be reduced in relation to those specified in this Recommendation 8 4 Routine tests by a user 8 4 1 The national responsible body shall provide information on methods for using EBAS for specific applications 8 4 2 If required by the national responsible body the operator of an EBA shall carry out a test with a reference sample in the field before and after a series of tests in the laboratory or in the field The results of these tests shall be within the limits established by the national responsible body 8 4 3 If required by the national responsible body a chronological written record shall be maintained for each EBA and shall contain at least the results of all routine tests This record may be included in the metrological logbook 9 Test m
43. rinciple Let C 5 be the mass concentration of ethanol of an aqueous solution of ethanol When air is bubbled through such a solution the mass concentration C of ethanol in the air is given by Dubowski s formula Cr 0 04145 x 10 Co x exp 0 06583t wheretis the temperature in C For t 234 C 0 38866 x 103 Co G 2 2 Practical application The formula of G 2 1 demonstrates that different mass concentrations in the air can be obtained by varying the mass concentration of ethanol in the water but it is preferable to vary the proportion of air that has passed through the solution in the test gas The sketches on page 36 give two examples of bubble trains used in practice By using at least two bubble flasks in series a stable value of mass concentration at exit is achieved allowing a fairly large number of measurements to be made The temperature of the bath shall be held at 34 C to within 0 1 C Temperature corrections may be ap plied OIMLR 126 1998 E Legend for the diagrammatic sketch on page 35 CE non return valve CA thermal insulator bubble train see sketches E hnius solenoid valve Ej eiie solenoid valve for filling bellows closed during exhalation solenoid valve open during exhalation F nsns filter blends humidifier l ues diaphragm LP flow controller asses temperature regulator RD flow regulator S nnn bellows Vars actuator VM
44. shall be available for at least one minute 6 6 7 The EBA shall provide a signal e g blanking out of the indication whenever the effect of an interfering substance exceeds the maximum influence given in Annex C 6 7 Safety and security 6 7 1 The EBA shall be capable of being used under satisfactory hygienic conditions It shall be possible to change the mouthpiece see 6 16 for each measure ment mouthpieces shall be individually packaged 6 7 2 shall conform to relevant national regula tions 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 6 7 3 The means by which the EBA is adjusted particu larly devices for adjusting the sensitivity and the zero position shall not be accessible to the common operator or user 6 7 4 The EBA shall give an indication each time the upper limit of the measurement range specified in 6 1 is exceeded in the sample Beyond that limit no measurement result shall be given or the upper limit may be displayed provided that it cannot be in terpreted as being valid e g by displaying greater than 6 7 5 The means used to change from one mode of operation to another shall be inaccessible to the common operator or user of the EBA access shall be possible only by breaking a sealing device by entering a code or by some other equivalent procedure
45. sible to memorize the value that con stitutes the offence of driving or working under the influence of alcohol hereafter called the legal value taking into account the following quotient AP AC i j where i the measurement no i in the cycle j the measurement performed after i the absolute value of the difference between the mass concentrations corresponding to the plateau for measurements i and j in mg L AT the delay between measurements i and j ex pressed in minutes Note the decimal part of the minute shall be con sidered 1 2 2 First the measuring cycle shall involve 2 meas urements each corresponding to an exhalation separ ated in time by the larger of the following two values 2 minutes or the minimum time between 2 consecutive measure ments 38 OIMLR126 1998 E Where the two results are smaller the legal value the result of each measurement shall be de livered at the end of the second measurement Where thetwo results are not smaller than the legal value the quotient AP shall be considered by the If AP is greater than 15 ugL 1min the EBA shall deliver a message such as Wait 10 minutes and restart the measuring cycle If AP is less than or equal to 15 ugL min then a third measurement shall be required by the EBA to be performed 10 minutes after the second one Where AP is less than or equal to 15 ugL min then the sm
46. sual and technical examination see pages 25 26 E 7 Conclusion of tests see pages 27 28 E 8 Test method In the case where this Recommendation indicates a recommended number of tests or recommended test values these numbers shall be used in the framework of the OIML Certificate System The test report shall indicate what test means were used Where test means did not conform to this Recommenda tion necessary descriptions shall be developed Where this Recommendation offers an alternative the solution implemented shall be indicated Any assumption or results of tests necessary to demonstrate the equivalence of results shall be given In case of dry gases the capability of the EBA to measure moist gases shall be demonstrated Where simplified test means were used see 9 1 8 the correction using the error under reference conditions shall be indicated Any problem observed on the EBA shall be mentioned Any useful information about test conditions ambient temperature humidity etc shall be indicated E 9 Example of test results sheet According to the requirements errors shall meet maximum permissible errors mpe or a maximum deviation is allowed test results shall be indicated on different documents see examples hereafter E 10 Brief statement of general conclusion as to whether the samples tested met the requirements of this Recommendation E 11 Person s responsible for the testing elle zu EP i o
47. surements should be made in each test condition except if the test method requires otherwise Every time that a disturbance renders the EBA incapable of giving a result it is advisable to the extent that it is practicable to retest at a reduced level of disturbance in order to verify that the results at these levels conform to the specifications The values of the parameters specified in this Annex shall be as near as possible to the values specified always taking into account the characteristics of test apparatus commercially available Where applicable tests shall be conducted in accord ance with IEC Publications 801 1 to 4 68 2 6 68 2 30 and with ISO Standard 7637 Electrical disturbance by conduction and coupling Part 1 vehicles with nominal 12 V supply voltage Part 2 commercial vehicles with nominal 24V supply voltage 0 1 Short time power reduction for AC mains powered E BA s Test method The disturbances shall be applied during a meas uring cycle The supply voltage shall be reduced by 100 for approximately half a mains cycle The supply voltage shall be reduced by 50 for approximately one mains cycle The time interval between successive disturbances Shall be at least 10 s Requirements Results obtained respectively with and without the disturbances specified above shall not differ by more than the absolute value of the maximum permissible errors in 5 1 1 or the EBA shall not g
48. tecting ethanol in the upper respiratory tracts in some cases a subjects physiology is such that further provisions are necessary to ensure that accurate evi dential readings may be obtained 1 1 Provisions applicable to non portable E BA s 1 1 1 In normal operation the measuring cycle shall involve two measurements each corresponding to an exhalation 1 1 2 The result of each measurement shall be de livered at the end of the measuring cycle 1 1 3 Users should be aware that it is advisable to perform further investigations for example a second measurement cycle when the difference between the two measurements of a cycle exceeds the greater of the following two values 10 96 in relative value of the smallest measurement Or 0 032 mg L In such occurrences the legal authority may require that the EBA automatically either deliver a warning or invalidate the cycle 1 1 4 Provisions 1 1 1 to 1 1 3 do not apply if the EBA fulfills the provisions in 1 2 1 2 Provisions applicable to portable 1 2 1 To ensure an accurate reading EBAS shall con tinuously monitor the evolution of the mass concen tration during an exhalation For application of the following provisions they shall take into consideration the mass concentration corres ponding to the plateau in the curve and not any other mass concentration They shall also measure the time difference between two consecutive measurements It shall be pos
49. ted with the EBA every time the latter is submitted for statutory metrological control Thelogbook which shall carry information identifying it with the EBA shall contain a recorded entry of every metrological operation and results that has been performed under statutory metrological control it shall also contain a record of any repairs that may affect metrological characteristics or performance of the EBA 8 Metrological controls It is recommended that national regulations provide for the following control procedures pattern approval initial verification of new EBAS periodic verification Note Provisions applying to verification after repair are left to national regulations 8 1 Pattern approval 8 1 1 Manufacturers shall provide the national responsible body with technical documentation and a user manual for the EBA and device for adjustment to a standard and may provide data and other informa tion on performance tests and calibrations that support a determination of whether the design of the EBA meets the requirements of this Recommendation 8 1 2 The user manual shall be reviewed by the national responsible body for its completeness and clarity of operating instructions The EBA and technical documentation shall be visually inspected in conjunction with a review of specifications provided by the manufacturer to determine that requirements 6 1 through 6 16 are met 10 OIMLR126 1998 E 8 1 3 The
50. y of 0 1 C it is the tolerance on the nominal temperature of calibration gases in use 4 Physical quantities and units of measurement shall be capable of expressing measurement results in terms of ethanol content in the exhaled breath at measuring conditions for example mass concentration of ethanol per unit volume In this Recommendation the unit of measurement used is the milligram of ethanol per litre of exhaled breath mg L 5 Metrological requirements The requirements of clause 5 are applicable to indi vidual measurements and not to any combination of measurements of a measuring cycle 5 1 Maximum permissible errors 5 1 1 Maximum permissible errors for pattern evaluation and initial verification The maximum permissible errors positive or negative on each indication shall be 0 020 mg L for all mass concentrations less than 0 400 mg L 596 of the measured concentration for all mass concentrations greater than or equal to 0 400 mg L and less than or equal to 2 000 mg L 2096 of the measured concentration for all mass concentrations greater than 2 000 mg L 5 1 2 Maximum permissible errors for E BAs in service The recommended values of maximum permissible errors positive or negative on each indication for EBAS in service are 0 032 mg L for all mass concentrations less than 0 400 mg L 896 of the measured concentration for all mass concentrations greater than or equal to 0 400 mg
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