TITLE OF THE CD (English): Revision OIML R 126 TITLE OF THE
Contents
1. The breath alcohol analyser shall be capable of measuring all mass concentrations in the range 0 00 mg L to at least 2 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 to be removed 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 3 2 2 Physical influence factors The rated operating conditions corresponding to the physical influence factors are specify in A 7 for the following performance tests e Dry heat A 7 1 e Cold A 7 2 e Damp heat steady state A 7 3 e Random vibrations A 7 4 e Voltage vibrations A 7 5 e Frequency vibrations A 7 6 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 8 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers 3 3 3 4 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 Pressure2. breath 2 5 Lin 5 s flow rate 0 5 L s dead volume 150 mL plate reached for a concentration 99 5 in 2 2 s 100 00 amp 80 00 c 2 60 00 5 8 40 00 c e 20 00 0 00 l l 0 1 2 3 4 5 time s Concentration simulation of curve C f t breath 2 Lin 5 s flow rate 0 4 L s dead volume 150 mL plate reached for a concentration 99 5 in2s 100 00 80 00 c 2 60 00 5 40 00 e 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 lst Committee Draft Recommendation on Breath Alcohol Analysers Page 32 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 recording of the curve of alcohol concentration expressed in according to time breath 3 Lin 5 s dead volume 150 mL plate reached in 2 5 s for 99 5 of alcohol 120 00 100 00 80 00 60 00 40 00 alcohol concentration 20 00 0 1 2 3 4 5 time of exhalation s lst Committee Draft Recommendation on Breath Alcohol Analysers Page 33 34 TC 17 SC 7 Breath Alcohol Analysers April 2006 Annexe D Test Report Format To be developed when the list of test is finalised Ist Committee Draft Recommendation on Breath Alcoh
3. 2 12 2 13 2 14 2 15 2 16 Metrological requirements 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 Technical requirements 4 1 4 2 4 3 4 4 4 5 Mobile breath alcohol analyser ccecccessceesceeeeeeeeseeeteeeseeeseeesees Handheld breath alcohol analyser ccceescceseceseceseceeeeeeeeeseeeseeessees AD Ve lar ates cigs cs vcoas sys saca phasis fone e a a Eae EEEa E ES Enid X piratory Air oerein a ei dead anatomical VOLUME ceceseeeececeeeeeeceseeaeeeeceaeceeeeeeaecnaeeneeeees Measuring mode ccccecccccsseessecsseceeeceseceseceeceeecseeeeeeeeeseeeseeeeeeneeeatees Maintenance mode 0 0 ceeescesecsseeseeecceceeeseceaecaeeeeceaecaeeeeeesecnaeeneeeees Adjustment device ccccecccccscesscessseeseeeseecssecssecesecnseceaeeseeeseeeenneennes Falt OIME DIT IIJ sac ssintrescke cca costae i ee Significant fault OIML D11 3 10 oo ccccceesseeeteceteeeteeeteeneeeeees Checking facility OIML D 11 3 18 ooo ececccseesteceteeeteeeteenteeees Built in automatic checking facility 0 0 0 cecccesceeeeeeeeeeeeeeeeeeees Memory residual effect cccccccescceseceseceeeeeeeeeeeeeeseeeseeeseeeeeeaees Representativity of the measurement cceccecseeseeteeeteeeteeetseetees Rated operating conditions ce eceecceseeseeesceeeeeeeeeseceeeeeesecnaeeaeenees Maximal permissible errors MPE cecceseeeceeseeeeceeeeeeeecneeeeeeeees Disturbances and other influence quantities cccecceesseeseesee
4. greater than or equal to 10 hPa new proposition 20 hPa to be discussed e Flowrate greater than to equal 0 10 L s 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 examination 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 Recommended maximum permissible errors for breath alcohol analysers in service 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 Disturbances and other influence quantities 3 4 1 Disturbances In the present of a disturbance the breath alcohol analyser shall present 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
5. 0 2 L e duration of injection 15s 0 5 s A 6 3 Influence of the breath profile e First test e delivered volume 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 ofinjection 5 s 0 5 s e type of profile forceful expiry according to annex C1 A 6 4 Influence of the flow rate 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 19 34 TC 17 SC 7 Breath Alcohol Analysers A 6 5 Influence of interruption in the flow breath e First test the injection of gas normally required for the reference conditions specified in A 3 shall be stopped 1 second 0 5 s after the start of injection e Second test the injection of gas normally required at least 15 s see A 6 2 shall be stopped 6 seconds 1 s after the start of injection A 7 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 For each test condition and each measurement the maximum permissible er
6. 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 9 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 3 4 2 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 Other influence quantities 3 4 2 1 Physiological influence quantities The corresponding test and acceptance criteria are specify in A 9 interfering substances and A 10 volumic fraction of CO2 3 4 2 2 Influence of substance in ambient air The instrument shall fulfilled 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 4 2 3 Influence of atmospheric pressure The corresponding test and acceptance criteria are specify in A 11 3 5 Repeatability 3 5 1 3 5 2 3 6 Drift 3 6 1 3 6 2 Experimental standard deviation The experimental standard deviation is given by the formula 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 Requirements The experimental standard deviation for all mass concentrations shall be
7. conducted with the maximum frequency allowed by the breath alcohol 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 15 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers A 3 1 A 3 2 A 3 3 Unless otherwise specified the test gas injected continuously into the breath alcohol analyser shall be characterised by the following parametric values Delivered volume 2 L 0 3 L Total duration of injection into breath analyser 5 s 0 5 s Type of profile constant flow rate Relative humidity of the gas at least 95 Gas temperature 34 C 0 5 C carrier gas pure air 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 reference gases was established Demonstration of the capability of the breath alcohol analyser to make measurements end expiratory air In order to demonstrate the capability of the breath alcohol analyser to make measurements on the end expiratory air the apparatus used by the laboratory shall permit to perform tests defined in Annex A 6 corresponding to the breath profile d
8. 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 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 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 connexion ca
9. less or equal to one third of the maximum permissible error Zero drift The zero drift shall be less than 0 010 mg L in 4 hours under reference conditions as defined in Annex A 5 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 5 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 10 34 TC 17 SC 7 Breath Alcohol Analysers 3 7 3 8 4 4 1 4 2 4 3 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 as defined in Annex A 5 Memory and residual effect 3 7 1 Memory effect The memory effect shall be less than 0 01 mg l when the test is conducted according to Annex A 5 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 smaller than or equal to the maximum permissible error for the lower mass concentration Durability All the test specified in this recommendation shall be performed on the same instrument in order to demonstrate the durability of the instrument Technical requirements 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
10. measuring instrument luminous signal acoustic signal prevention of the measurement process etc Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 7 34 TC 17 SC 7 Breath Alcohol Analysers 2 14 2 15 2 16 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 or additional checking externals elements to be connected to the instrument such as optical or electrical filters or cylinder with a know 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 Representativity of the measurement The breath alcohol analyser shall be able to guarantee that the measurement result is representative of the alcohol concentration present in the end expiratory air 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 6 Rated operating conditions 3 2 1 Measuring range
11. on a table which can generate shakes in the following conditions wave shape half sinusoid e amplitude 10 g g 9 81 m s e duration 6 ms e frequency 2 Hz e number of axes 3 perpendicular axes e number of shakes 1000 for each axes Damp heat cyclic 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 maintained at the lower value during 9 h Mobile Handheld Temperature 30 C 40 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 two 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 After a recovery period of one hour the error of the breath alcohol analyser is determined and the default is calculated A 9 Ph
12. shall deliver no measurement result Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 27 34 TC 17 SC 7 Breath Alcohol Analysers B 2 B 3 Two measurement cycle 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 more than or equal to the legal value it is necessary to calculate the ratio R t where t is the time difference between the end of the first breath and the end of eo C the second breath 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 measur
13. the compressibility factor between filling and usage conditions are taken into account the quality of the containers 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 test facilities must be taken into account in calculations of uncertainties of the measurement Reference conditions Ambient temperature 23 C S C Relative humidity 50 30 Atmospheric pressure 1013 20 hPa Total fraction by volume of hydrocarbons as methane equivalent in the environment lt 2 ppm During each test the temperature and the relative humidity shall not vary by more than 5 C and 10 respectively within the reference range A 5 A 5 1 Accuracy tests 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 scale 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 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 measurements shall comply with the maximum permissible erro
14. 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 Line to line 1 kV Unbalanced lines Line to earth 2 kV Balanced lines Line to earth 2 kV AC mains voltage dips short interruptions and voltage variations See OIML D 11 13 4 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 23 34 TC 17 SC 7 Breath Alcohol Analysers A 8 8 A 8 9 Ist Committee Draft Recommendation on Breath Alcohol Analysers 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 April 2006 The error of the breath alcohol analyser is det
15. Annex C General information and breath profile mandatory Annexe D Test Report Format Ist Committee Draft Recommendation on Breath Alcohol Analysers 15 15 15 15 17 17 18 20 22 25 26 26 27 27 28 28 29 34 Page 5 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers Requirements 1 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 alcohol impregnation of the subject However for the purpose of this recommendation only ethanol is considered as alcohol Hereinafter ethanol is alcohol This Recommendation does not apply to instruments which do not indicate the result of measurement but which only indicate whether the mass concentration of alcohol exceeds the allowed limits National authorities may require that breath alcohol analysers are equipped with special devices according to the national policy for fighting against alcoholism such as e device 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 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 information National authorities may require that the breath alcohol analys
16. Stationary Stationary or AC mains voltage DC mains voltage handheld 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 in 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 e Lower limit limit where the instrument ceases to operate in the MPE AC mains frequency variations See OIML D 11 11 1 1 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 21 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers 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 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 if the test method requires otherwise 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
17. TC 17 SC 7 Breath Alcohol Analysers April 2006 COMMITTEE DRAFT OIML CD2 Date 21 April 2006 Reference number Supersedes document OIML R 126 CDI OIML TC 17 SC 7 Circulated to P and O members and liaison international bodies and external organisations for Title OIML R 126 Breath alcohol analysers discussion planned at a meeting to be held in April 2007 to be confirmed Secretariat France comments by 15 September vote P members only and comments by cell oe N So S TITLE OF THE CD English Revision OIML R 126 Breath alcohol analysers TITLE OF THE CD French Ethylom tres Original version in English Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 1 34 TC 17 SC 7 Breath Alcohol Analysers TCO17 SC7 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 2 34 April 2006 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
18. air The mass concentration shall be indicated in milligram per litre of exhaled breath mg L The reference conditions for all measurement alcohol concentration including calibration are Temperature 34 0 C Pressure to be discuss hPa Humidity 95 HR in the pressure condition during the breath Presence of CO 5 Scale interval The scale interval is 0 01 mg L in the measuring mode Nevertheless in the maintenance mode it shall be possible to display with a scale interval equal to 0 001 mg L Display The result of measurement shall be displayed digitally by means of aligned figures The display in the measuring mode shall consist on 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 11 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers 4 4 4 5 4 6 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 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 In the
19. ation 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 5 measurements using test gas n 3 The mean value of these 5 measurements is calculated The difference between these two mean values shall comply with the requirement specified in 3 7 2 A 6 Influence factors in the parameters which characterise the test gases A 6 1 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 introduction of A 3 The values of the parameters to be varied are specified in A 6 1 to A 6 7 For each test 10 measurements using test gas n 4 shall be performed Each of this 10 measurements shall fulfilled the maximum permissible error requirement defined in 3 3 1 Influence of delivered volume e First test e delivered volume 1 2 L 0 1 L 0 5 s e duration ofinjection 4 s Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 18 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 e Second test e delivered volume 4 5 L 0 3 L e duration of injection 15 s 0 5 s A 6 2 Influence of the duration of exhalation e First test e delivered volume 2 5 L 0 2 L e duration of injection 5 s 0 5 s e Second test e delivered volume 2 5 L
20. ay be used outside buildings or mobile laboratories Alveolar air Air contained in the pulmonary alveoli where the gaseous exchange takes place End expiratory air Air considered sufficiently representative of alveolar air in opposition to air anatomical dead 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 calibrated and subject to metrological testing and control Adjustment device A device for adjusting the breath alcohol analyser when it is in maintenance mode 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 corrected Fault OIML D11 3 9 Difference between the error of indication and the intrinsic error of a measuring instrument Significant fault OIML D11 3 10 Fault greater than value specified in the relevant Recommendation Checking facility OIML D 11 3 18 Facility that is incorporated in a measuring instrument and which enables significant faults to be detected and acted upon Note acted upon refers to any adequate response by the
21. bles if the instrument is composed of several elements connected together For that connexion cables the test shall be performed at each extremity of the cables if both of the elements are part of the instrument Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 22 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 A 8 3 A 8 4 A 8 5 A 8 6 A 8 7 The test conditions are the following Frequency range from 0 15 MHz to 26 MHz Modulation 80 AM 1 kHz sine wave RF amplitude 50 Q 10 V 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 e Indirect application The discharges shall be applied on each surface accessible in normal operation At least ten successive discharges shall 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
22. d at the end of the test after a recovery period of one hour Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 20 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers A 7 4 A 7 5 A 7 6 Mobile Handheld Temperature 30 C 40 C Humidity 85 rel 93 rel Duration 2 days 4 days Random vibrations See OIML D 11 11 1 1 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 minimum 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 the voltage if applicable when the instrument is powered on at the lower limit of the voltage Stationary
23. ed National responsible bodies may decide to test the influence of other compounds A 10 Influence of volume fraction of CO e Mass concentration by volume of CO2 10 1 A 11 Influence of atmospheric pressure e First test Atmospheric pressure 860 hPa 10 hPa e Second test Atmospheric pressure 1060 hPa 10 hPa Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 26 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 B 1 Annex B Examples of detection of alcohol in upper respiratory tracks informative The member State may choose one two or all the following solutions for detection of alcohol in the upper respiratory tracks B1 or B2 or avoiding the corresponding influence B3 Pic method In the event that the breath alcohol analyser operates with the detection of a pic the following test allows demonstrating that the instrument is able to detect alcohol in upper respiratory tracks The test consists in injecting a test gas providing an evolution of the mass concentration as indicated below C mg L A 0 4 j Maximum Plateau a gt Time s 0 l mgL s 4 10 15 The characteristics of the gas injected are the following e delivered volume 3L e duration 15s e mass concentration at maximum of the curve 0 4 mg L Ten measurements shall be performed and the instrument shall detect the presence of alcohol in the upper respiratory tracks and
24. ees Memory and residual effect cccccesccescessceeeceeeeeeeeeeeeeeeeeeeseeesees D rability ve 2c sec 8 cs een a os Steg bake ed ag de des Bate Tada Bate ok Physical quantity and unit of measurement eee eseeeeceeeeeeeees Scale intervalos nrrainn ois ee an E o S AEE EE T EERS IDS ENEE EA E EREE ETE E PrimtinS EV E a a E SaS E N a a Measuring conditions ccceseceseceseceeceeeeseceeeceeeeeeeeeeseeeseeeseeceeesaees Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 3 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 4 6 Checking Operations is ssas E a E N E A atv deat lata Boles 12 AT Suitability fOr Usen a a e a tesserae ewes 13 4 8 Marking and sealing iu nanni ena tna a N R A odin ani 13 Dr Type eval LATO a MEENE A E 13 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 4 34 TC 17 SC 7 Breath Alcohol Analysers Annex A PERFORMANCE TESTS A l A 2 A3 A4 A 5 A 6 A 7 A 8 A A 10 A 11 General Breath profile Tests facilities Reference conditions Accuracy tests Influence factors in the parameters which characterise the test gases Physical influence factors Disturbances tests Physiological influence quantities Influence of volume fraction of CO2 Influence of atmospheric pressure Annex B Examples of detection of alcohol in upper respiratory tracks B 1 B 2 B 3 Pic method Two measurement cycle Delay before measurement
25. ement 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 Delay before measurement An other solution to deal with alcohol in the upper respiratory tracks is waiting before performing measurements A delay of 30 min is considered as a reasonable one Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 28 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 Annex C General information and breath profile mandatory C 1 MEASUREMENT FLOW RATE DURING EXHALATION Curves of the flow rate as a function of volume obtained from a human exhalation Theoretical curves The flow is very strong at the beginning of the exhalation 75 of total volumes are expired during the first second of the breath The flow varies from 5 to 10 L s E E Sa DEM25 Volume oy VEMS The curve flow rate volume starts with zero at the point of intersection of the axes x and y flow rate 0 and volume 0 The point where the curve touch axis x is the CVF the totality of mobilized pulmonary volume is expired Immediately after the departure of the breath the flow increases very quickly to reach
26. ermined for each configuration of testing For voltage interruption the test conditions are the following gt 95 250 cycles e Interruption e Duration 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 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 Dules ortesi 5000 pulses 5000 pulses 1 hour 1 pulse time Mechanical shocks See OIML D 11 11 2 e For stationary or and mobile alcohol breath 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 surface 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 3 arbitrary positions are chosen Stationary Mobile handheld Height of fall 25 mm 50 mm lm Number of fall l l 3 Page 24 34 TC 17 SC 7 Breath Alcohol Analysers April 2006 A 8 10 A 8 11 A 8 12 Shakes This test simulates shocks in a car trunk The breath alcohol analyser is placed in its reference position
27. ers 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 and initial verification of breath alcohol analysers owing to national differences in legal systems 2 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 alcohol impregnation of the subject 2 2 Stationary breath alcohol analyser A breath alcohol analyser intended only for use within buildings or places providing similar environmental conditions 1 However it is advisable that national penal law defines offences in terms of alcohol in breath so that these instruments are more appropriately used Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 6 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 2 3 2 4 2 5 2 6 2 7 2 8 2 9 2 10 2 11 2 12 2 13 Mobile breath alcohol analyser A breath alcohol analyser intended for use in mobile laboratory applications e g in cars Handheld breath alcohol analyser A hand portable breath alcohol analyser that m
28. escribe 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 is injected 10 of total volume 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 concentration during injection The completed test reports shall indicate when such alternative tests means have been implemented For other tests than accuracy tests and tests 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 7 4 A 7 5 A 7 6 A 8 1 to A 8 10 included e Gases without CO7 which can be used for tests defined in A 7 A 8 and A 11 In all cases the evolution of the concentration and the flow rate during injection may be constant Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 16 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 For cases involving dry gases in containers variations of atmospheric pressure and variation of
29. ic adjustment or checking of adjustment implementing the building in automatic checking facility and from the moment it indicates that it is ready to receive an exhalation the breath alcohol analyser shall be available at least one minute 4 7 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 delay the result remains accessible 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 measurement range stationary mobile or portable e ambient temperature range power supply range Instruments shall also bear a label saying that sucking should be avoided instead of blowing Appropriate sealing shall protect the integrity of the instruments Type evaluation 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 calibrati
30. imulation of a forced exhalation Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 30 34 TC 17 SC 7 Breath Alcohol Analysers April 2006 C 2 MEASUREMENT ALCOHOL DURING EXHALATION DETERMINATION OF THE ALCOHOL PLATEAU Curves of the alcohol concentration as a function of time obtained from a human exhalation Theoretical 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 D a 00 Cu i t tity C Oar i i 1 Vm C 0 i incremental indice where C alcohol concentration expressed in D flow rate L s t time of exhalation s Vm dead anatomical volume L 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 Standard uncertainty on the alcohol concentration determined by a plateau and its variations must be taken into account in the global calculation of the expending uncertainty of the test facilities in accordance with the requirement of chapter A 3 note 1 3 EMT Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 31 34 TC 17 SC 7 Breath Alcohol Analysers simulation of a curve C f t
31. its maximum in approximately 100 milliseconds This point is named the Point of high Expiratory Flow EPD in spirometry The EPD represents the exhalation of air expired of the anatomic dead volume After the EPD the curve is on line goes down the flow drops though there is more expired volume The flow continues to decline for finally reaching zero end of the test Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 29 34 TC 17 SC 7 Breath Alcohol Analysers April 2006 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 recording curve of flow rate during a forceful expiry during an humain breath through an EBA flow rate as a fonction of time iN a a f wo a wo nm oa 20 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 s
32. measuring mode 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 thirty days even when exposed to daylight or equivalent lighting 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 e presence of paper the electronic control circuits Measuring conditions At least before each measurement the instrument shall automatically adjust or check adjustment implementing the building 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 not anymore ready to perform measurements it shall indicate it The breath alcohol analyser shall monitor the continuity of exhalation and shall give an indication if the flow of exhaled air is interrupted between the beginning and the end of the sa
33. mpling A signal preferably audible shall enable to 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 Optionally the breath alcohol analyser may 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 12 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers 4 7 4 8 Suitability for use 4 7 1 Warm up time Under reference conditions the breath alcohol analyser shall be capable of attaining the measuring mode e 15 minutes after being switched on e 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 breath alcohol analyser and provided in the user manual 4 7 2 Availability for measurement After successful checking operations automat
34. nditions for determining the intrinsic error Different kinds of tests apply Test related to the representativity of measurement Accuracy tests including repeatability drift and memory and residual effect Influence factors Disturbances 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 A 3 Breath profile The human breath 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 injection The mass concentration at this plateau represents the mass concentration in the end expiratory air Annex C2 shows the general form is this breath profile e Evolution of the flow rate curve during the breath Annex C1 shows the general form is this breath profile Tests 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 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
35. ol Analysers Page 34 34
36. ons that support a determination whether the design of the breath alcohol analyser meets the requirements of this Recommendation The technical documentation shall include Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 13 34 April 2006 TC 17 SC 7 Breath Alcohol Analysers April 2006 a list of the electronic sub assemblies with their essential characteristics e 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 e 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 Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 14 34 TC 17 SC 7 Breath Alcohol Analysers A l Annex A PERFORMANCE TESTS Mandatory 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 co
37. r requirement Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 17 34 TC 17 SC 7 Breath Alcohol Analysers A 5 2 A 5 3 Drift At least 10 initial measurements shall be made with each test gases n 1 and n 4 to verify the drift specifications defined in 3 6 Then 10 additional measurements are made using the same respective gases at the conclusion of the times intervals specified in 3 6 For each drift test the deviation between the mean value of the two series of measurements initial and additional shall fulfil the appropriate requirements in 3 6 Other tests provided for in this recommendation for type approval may be performed during the drift tests Memory and residual effect A 5 3 1 A 5 3 2 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 the upper use defined test gases limit of the measuring range whichever the 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 two calculated mean values shall be less than the limit specified in 3 7 1 Small changes in mass concentr
38. ror 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 7 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 Handheld Temperature 30 C 40 C 40 C or 50 C Duration 2 hours Number of cycle 1 Specified by the State A 7 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 Handheld Temperature 5 C 10 C 25 C or 10 C Duration 2 hours Number of cycle 1 Specified by the State A 7 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 humidity during the time defined below according to the severity level The error of the breath alcohol analyser is determined one time per day an
39. ysiological influence quantities The breath alcohol analyser shall be tested according to the following procedure Ist Committee Draft Recommendation on Breath Alcohol Analysers Page 25 34 TC 17 SC 7 Breath Alcohol Analysers 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 value defined in 0 1 mg L for the current interfering substance 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 signal is given the breath alcohol analyser has failed If a signal 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 fulfill
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