EN 15964-2011 en Breath alcohol test devices other than single use devices - Requirements and test methods《酒精呼吸测试设备其他比单独使用的设备 要求和测试方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 15964:2011Breath alcohol test devicesother than single use devices Requirements and testmethodsBS EN 15964:2011 BRITISH STANDARDNational forewordThis British Standard is th

2、e UK implementation of EN 15964:2011.In particular, compliance with this Standard will not of itself qualifya device for type approval for the conduct of preliminary breathtests under the Road Traffic Act 1988. A device will not be typeapproved unless it meets all the requirements set out in the Gui

3、de totype approval procedures for breath alcohol screening devices usedfor law enforcement in Great Britain, published by the Home Officeand available at http:/www.homeoffice.gov.uk/police/powers/road-traffic/road-traffic.html/ The UK participation in its preparation was entrusted to TechnicalCommit

4、tee PTI/15, Natural Gas and Gas Analysis.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 6

5、7651 2ICS 03.160; 13.320; 71.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2011.Amendments issued since publicationDate Text affectedBS EN 15964:20

6、11EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15964 March 2011 ICS 03.160; 71.040.40 English Version Breath alcohol test devices other than single use devices - Requirements and test methods Ethylotests, autres que les dispositifs usage unique - Exigences et mthodes dessais Atemalkohol-Test

7、gerte zur Mehrfachverwendung - Anforderungen und Prfverfahren This European Standard was approved by CEN on 29 January 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard wi

8、thout any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any othe

9、r language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,

10、Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMA

11、LISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15964:2011: EBS EN 15964:2011EN 15964:2011 (E) 2 Contents Page Foreword 4Introduction

12、 .51 Scope 62 Normative references 63 Terms and definitions .74 Type-testing 85 Safety 85.1 General comments.85.2 Hygiene .85.3 Electrical safety86 General specifications 86.1 General requirements 86.2 Maximum permissible error (MPE).96.3 Measurement range .96.4 Operating environmental conditions .9

13、6.4.1 Temperature .96.4.2 Humidity 96.5 Ease of use .96.6 Breath sampling method .96.7 Expression of results 96.7.1 Units of measurement .96.7.2 Rounding . 106.7.3 Display . 106.8 Adjustment 106.9 Start-up time 106.10 Frequency of measurement . 106.11 Power supply duration . 116.12 Data storage 116.

14、13 General device functions . 117 Metrological characteristics for testing . 117.1 General conditions . 117.2 Test gas characteristics . 127.3 Reference conditions . 127.4 Accuracy tests 127.4.1 General . 127.4.2 Accuracy testing . 137.4.3 Repeatability testing . 137.4.4 Drift testing 137.5 Memory e

15、ffects 147.5.1 Hysteresis 147.5.2 Effect of water vapour (condensation) . 147.6 Influence factors . 147.6.1 General . 147.6.2 Operating temperature . 147.6.3 Ambient relative humidity 157.6.4 Interfering substances . 157.6.5 Influence factors exhalation parameters 167.6.6 Voltage variation (internal

16、 battery) . 18BS EN 15964:2011EN 15964:2011 (E) 3 7.6.7 Power supply duration tests 187.7 Mechanical and climatic disturbances 197.7.1 General . 197.7.2 Shock minimum flowrate = 0,15 L/s; maximum pressure = 30 hPa at a flowrate of 0,2 L/s, mouthpiece attached. 6.7 Expression of results 6.7.1 Units o

17、f measurement In test mode the units of measurement shall be mg/L or equivalent unit. BS EN 15964:2011EN 15964:2011 (E) 10 6.7.2 Rounding In test mode, the device shall display the result of each test to the nearest 0,001 mg/L or equivalent unit. In normal mode, it shall report the result of each te

18、st rounded down to the nearest scale interval of 0,01 mg/L or equivalent when in digital format and the appropriate band when in indicating format. 6.7.3 Display The units of measurement shall be displayed in the vicinity of the result. The result of measurement of the alcohol content of the breath

19、specimen may be presented in two ways: indicating format where the alcohol content of the sample is presented by a system of lights or characters on an alpha-numeric display; digital format where the alcohol concentration is expressed in a quantitative format. It shall be permissible for a device to

20、 indicate zero for values up to and including 0,03 mg/L; It shall be permissible for a device to operate in indicating and digital format simultaneously. It shall not be possible for the display to be converted from indicating format to digital format in normal mode. The display shall permit easy re

21、ading of the results in all levels of ambient light. The results and other indications shall be able to be observed for at least one minute or alternatively it shall be possible to recall the result of the last test. However, a new measurement shall be able to be initiated at any time during the dis

22、play of the result. 6.8 Adjustment The procedure and equipment for adjusting the breath alcohol test device to a reference alcohol mass concentration shall be supplied by the manufacturer. For this purpose, the gas may be dry or wet, provided it can be shown on the device that the results from each

23、are equivalent. The required period between two successive adjustments shall be at least three months. During this period the results shall remain stable (see 7.4.4). 6.9 Start-up time Within the specified operating temperature range, the device shall be ready to carry out a measurement in less than

24、 3 minutes after switching on. 6.10 Frequency of measurement The maximum allowed time between two measurements shall be: 1 min for a concentration 0,05 mg/L; 2 min for a concentration 0,05 mg/L and 0,40 mg/L; 3 min for a concentration 0,40 mg/L and 2,0 mg/L. BS EN 15964:2011EN 15964:2011 (E) 11 6.11

25、 Power supply duration Devices shall have an internal power supply. With batteries fully charged, the breath alcohol test device shall be able to perform at least 75 individual measurements, each from switch on to result displayed within the operating temperature range. 6.12 Data storage When a perm

26、anent data memory is provided the downloaded data shall include at least: serial number of the device; date and time of the test; type of test (e.g. normal mode); measurement result or an indication that the test was not completed; unit of measurement if applicable. The device shall give a warning i

27、f the memory is approaching the limit of its capacity (see also requirements in Clause 9). 6.13 General device functions In addition to the breath alcohol testing requirements, checks shall be made on general device functions to ensure that the device performs in accordance with the manufacturers in

28、formation. 7 Metrological characteristics for testing 7.1 General conditions Immediately prior to testing and if appropriate, the device may undergo adjustment to a reference ethanol vapour test gas. For example, in case of lot by lot testing, the manufacturer shall perform the adjustment. Perform t

29、he tests at the maximum rate authorised by the provided features, taking into account the test equipment possibilities. The tests shall be able to check that the devices comply with the provisions of this document in the different submitted power supply configurations. The effect of each factor shal

30、l be determined in turn with all other factors being at their reference level. The effects shall not be combined unless otherwise specified. In performing the tests in this scheme a complete breath test using the standard vapours shall be carried out. Wherever possible, the test shall allow all aspe

31、cts of the normal operation of the device to be verified. Tests shall be run at the reference point and the extreme points of each condition listed. The power supply used shall be of the type recommended by the manufacturer. The following tests shall be carried out on a device representative of devi

32、ces intended for use and without any additional protective means. BS EN 15964:2011EN 15964:2011 (E) 12 7.2 Test gas characteristics The gas used shall be wet gas unless otherwise stated for a particular test. Wet gas shall be generated at a temperature of (34,0 0,5) C with a relative humidity of at

33、least 90 %. The carrier gas shall have 5 % of CO2(volumetric fractions). If the influence of 5 % of CO2is no more than 0,01 mg/L for a concentration of 0,4 mg/L of ethanol then the carrier gas may be air. If changes of the O2 concentration in the carrier gas are relevant, the constitution of the car

34、rier gas shall reflect the O2concentration of human breath which may vary between 12 vol % and 21 vol %. The uncertainty of test gas concentration shall be 1/3 of MPE. The concentration of ethanol in the wet gas is calculated on the basis of the formula detailed in Annex B. 7.3 Reference conditions

35、The reference conditions defined for the tests are as follows: Temperature: ambient temperature: (22 4) C; humidity: ambient air humidity (50 30) % RH; atmospheric pressure: ambient atmospheric pressure; test gas flow: (0,20 0,05) L/s; volume: (1,5 0,1) L. If required by the test device, the test ga

36、s flow rate shall be reduced to allow the device to take a sample of the test gas for analysis. Regardless of the selected mode (normal or test mode), the device shall be tested the way it is normally used. For a breath alcohol test device that is not capable of displaying the measured concentration

37、, the manufacturer shall provide the necessary methods to be able to obtain quantitative readings for the purpose of testing the compliance of the breath alcohol test device with the requirement of this European Standard. 7.4 Accuracy tests 7.4.1 General The device shall be tested with the number an

38、d concentration of test gases listed in Table 1 in 7.4.2. The individual results and the average results shall be within the error limits indicated for each test gas. BS EN 15964:2011EN 15964:2011 (E) 13 7.4.2 Accuracy testing For accuracy, the following concentrations and number of measurements sha

39、ll be used for the tests: Table 1 Concentration (mg/L) Number of measurements 0,00 10 0,10 200,25 200,40 20 0,60 10If digital values are required above 0,60 mg/L, the accuracy has to be tested ten times at 90 % of the maximum value, e.g. at 1,80 mg/L for the maximum range given in 6.3. If no digital

40、 values are required above 0,60 mg/L, the functionality of the device up to the maximum value of the measurement range has to be checked. If a device displays the result of the test in indicating format above a certain concentration, it shall only be checked whether the device gives the right indica

41、tion at higher concentrations in normal mode. Acceptance criteria: each obtained value shall comply with the MPE defined in 6.2. 7.4.3 Repeatability testing The repeatability shall be determined at 0,10 mg/L and 0,40 mg/L. Twenty consecutive results are required at each level. Acceptance criteria: e

42、ach obtained value shall comply with the MPE defined in 6.2; maximum standard deviation (SD) for repeatability, at 0,10 mg/L alcohol concentration: 0,012 mg/L; maximum coefficient of variation (CV) for repeatability, at 0,40 mg/L alcohol concentration: 3 %. 7.4.4 Drift testing For drift, the followi

43、ng values shall be used: two levels of concentration: 0,10 mg/L and 0,40 mg/L; five measurements at each of the two levels, once a week for three months. Acceptance criteria: each measurement result shall comply with the MPE as defined in 6.2. In addition, the average of each set of five measurement

44、s shall be calculated. The maximum difference between the averages shall be 0,020 mg/L (per week/3 months). BS EN 15964:2011EN 15964:2011 (E) 14 7.5 Memory effects 7.5.1 Hysteresis Subject the device ten times to the following cycle: perform a measurement with a concentration of 1 mg/L; perform a me

45、asurement with a concentration of 0,10 mg/L; Acceptance criteria: each obtained value shall comply with the MPE defined in 6.2. 7.5.2 Effect of water vapour (condensation) Perform the following tests at 5 C: ten measurements at 0,00 mg/L at the maximum rate permitted by the device; five measurements

46、 at 0,40 mg/L. Acceptance criteria: each obtained value shall comply with the MPE defined in 6.2. 7.6 Influence factors 7.6.1 General Regarding influence factors, the following procedure shall be applied unless otherwise specified in this chapter: Test ten measurements at 0,10 mg/L and ten measureme

47、nts at 0,40 mg/L. Acceptance criteria: each obtained value shall comply with the MPE defined in 6.2. If the manufacturer specifies extended operating conditions different to those stated the device shall be tested to those conditions. 7.6.2 Operating temperature The following test procedure shall be

48、 applied: a first test is done at the reference conditions; then a test is done at 5 C; then a test is done at + 40 C; then a test is done at the reference conditions. The device under test shall be placed in the test chamber at the reference temperature and a test shall be carried out. The temperature shall then be reduced to the minimum specified and the device under test allowed to stabilise for at least 3 h. A test shall be carried out. The temperature shall then be raised to the maximum level in not less than 1 h to minimise the risk of condensation occurring and the device