1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 16280:2012Breath alcohol test devices forgeneral public Requirementsand test methodsBS EN 16280:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implem
2、entation of EN 16280:2012.BSI, as a member of CEN, is obliged to publish EN 16280:2012 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted against its approval as a European Standard.It should be noted that in t
3、he UK, use of breath test devices by members of the public to determine whether or not they might be over the drink drive limit is not encouraged. There is a risk that improper use of such non-professional devices could mistakenly lead individuals to think they were not impaired or above the limit,
4、thereby threatening road safety.The UK committee would like to point out that devices used by the police have to meet stringent type approval standards. Public confidence in these could be diminished by the use of other devices which might conform to other standards but are not type approved. Other
5、devices might not operate with the same accuracy and could in any particular case give a different reading; these scenarios could have legal implications.In the UK, a device will not be type approved unless it meets all the requirements set out in the Guide to Type Approval for Electronic Breath Scr
6、eening Devices (ESDs) used for law enforcement in Great Britain, published by the Home Office and is available here: http:/ www.homeoffice.gov.uk/publications/police/road-traffic-documents/ breathalcoholscreening.pdf?view=BinaryThe UK participation in its preparation was entrusted to Technical Commi
7、ttee PTI/15, Natural Gas and Gas Analysis.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standard
8、s Institution 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 74900 1ICS 13.320; 71.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November
9、 2012.Amendments issued since publicationDate Text affectedBS EN 16280:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16280 October 2012 ICS 13.320; 71.040.40 English Version Breath alcohol test devices for general public - Requirements and test methods Ethylotests pour le grand public - E
10、xigences et mthodes dessais Atemalkoholtestgerte fr den allgemeinen Gebrauch This European Standard was approved by CEN on 18 August 2012. 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 nation
11、al standard without 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 versi
12、on in any other 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, Cz
13、ech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
14、EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16280:2012: EBS EN 16280
15、:2012EN 16280:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Type-testing 65 Safety 65.1 General comments.65.2 Hygiene .75.3 Electrical safety76 General specifications 76.1 General requirements 76.2 Maximum permissible error (MPE).76.3
16、Measurement range .76.4 Operating environmental conditions .76.5 Ease of use .86.6 Breath sampling method .86.7 Expression of results 86.8 Adjustment .96.9 Calibration period 96.10 Start-up time .96.11 Time for accepting a specimen 96.12 Frequency of measurement 96.13 Power supply duration . 107 Met
17、rological characteristics for testing . 107.1 General conditions . 107.2 Test gas characteristics . 107.3 Reference conditions . 117.4 Accuracy tests 117.5 Memory effect 127.6 Influence factors . 127.7 Mechanical and climatic disturbances . 148 Marking 169 Operating instructions . 16Annex A (informa
18、tive) Example of type testing requirements . 18A.1 Additional information for compliance testing 18A.2 Certification procedure 18Annex B (informative) Figures for format 1 and format 2 - 6.7.4 Display (in normal mode) . 19Annex C (informative) Formula for wet gas alcohol concentration 21Bibliography
19、 . 22BS EN 16280:2012EN 16280:2012 (E) 3 Foreword This document (EN 16280:2012) has been prepared by Technical Committee CEN/TC 367 “Breath-alcohol testers”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of a
20、n identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be he
21、ld responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estoni
22、a, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16280:2012EN 16280:
23、2012 (E) 4 Introduction The two main objectives of breath testers, the specifications of which are defined in this document, consist, on the one hand, in contributing to the prevention of accidents related to the consumption of alcohol, in particular road accidents, and on the other hand, in educati
24、ng and making consumers aware of their responsibilities by enabling them to measure their breath alcohol level. The purpose of this standard is to define requirements for a device which is capable of producing measurements that will deter a person who has consumed alcohol from driving or carrying ou
25、t other risk-related activities. Any appropriate technology capable of providing the functionality required in this document may be used. The intention of the standard is to define specifications for a breath alcohol tester which will benefit to the general public at an affordable level. The require
26、ments in this standard apply for electronic devices only. BS EN 16280:2012EN 16280:2012 (E) 5 1 Scope This European Standard applies to breath alcohol test devices which measure the concentration of alcohol contained in an exhaled breath sample, designed and intended to be used as a self tester for
27、the general public and to provide a reliable indication of the breath alcohol concentration at the time of the test. This European Standard specifies requirements for basic safety and performance, test methods and requirements for marking, labelling and operating instructions. This European Standard
28、 gives guidelines for compliance testing procedures consisting of a number of technical performance tests. It is not intended that the results of these devices should be used to rebut the results of evidential breath alcohol analysers covered by OIML R 126:1998, or breath alcohol test devices used i
29、n professional applications covered by EN 15964 or similar national regulations. Therefore, the results of measurements need to be displayed so as to protect, as far as it is practicable, the user from underestimating his alcohol concentration based on measurement uncertainties, intrinsic in every m
30、easurement. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includi
31、ng any amendments) applies. EN 60068-2-1, Environmental testing Part 2-1: Tests Test A: Cold (IEC 60068-2-1) EN 60068-2-2, Environmental testing Part 2-2: Tests Test B: Dry heat (IEC 60068-2-2) EN 60068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle) (IEC
32、60068-2-30) EN 60068-2-32, Basic environmental testing procedures Part 2: Tests Test Ed: Free fall (IEC 60068-2-32) EN 60335-2-29, Household and similar electrical appliances Safety Part 2-29: Particular requirements for battery chargers (IEC 60335-2-29) 3 Terms and definitions For the purposes of t
33、his document, the following terms and definitions apply. 3.1 alcohol considered to be ethanol 3.2 breath alcohol test device device which accepts a breath specimen, measures the concentration and indicates the level of alcohol in that breath specimen 3.3 operating state state of the device in which
34、it is able to take a breath specimen and determine the alcohol level in that breath specimen BS EN 16280:2012EN 16280:2012 (E) 6 3.4 normal mode mode in which the device is ready to measure and display the level of alcohol in the breath specimen of the subject under test, either quantitatively or by
35、 preset level indication 3.5 test mode mode in which the device displays the result of a test specified in this standard expressed in numerical format 3.6 unit of measurement concentration of ethanol expressed in milligrams of ethanol per litre of exhaled volume (mg/L) Note 1 to entry: Concentration
36、 in ethanol may be expressed in any other equivalent units, e.g. g/L or g/100 ml. 3.7 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations
37、 are carried out by that person himself or on his behalf by a third party 3.8 Maximum Permissible Error MPE extreme allowed value of measurement with respect to a test gas concentration defined in this standard 3.9 adjustment process required to correct the measurement value of the breath alcohol te
38、st device when it is found to be outside of the defined MPE 3.10 calibration process required to establish a relation between the measurement value of the breath alcohol test device and a reference gas 3.11 mouthpiece disposable hygienically wrapped part that is fitted to the breath alcohol test dev
39、ice through which the subject under test provides the breath specimen, and that is used to prevent the breath sample being mixed with ambient air and diluting the alcohol concentration 4 Type-testing An example of type-testing requirements is described in Annex A (informative). 5 Safety 5.1 General
40、comments The device shall be designed as far as possible to ensure the safety of the user of the device. Particular attention shall be made to the design and use of electrical connections as well as the materials chosen for mouthpiece construction and packaging. BS EN 16280:2012EN 16280:2012 (E) 7 5
41、.2 Hygiene The device shall be capable of use under hygienic conditions. It shall preclude the possibility of inhaling contaminated air from previous usages. It shall be possible to insert and remove these mouthpieces without touching the part which will be in contact with the lips of the user. The
42、mouthpieces shall be supplied in individual, easily opened sealed packaging. 5.3 Electrical safety The device shall be capable of operating within the requirements of relevant electrical safety regulations and standards. A battery charger or an external power supply provided as an accessory to the d
43、evice shall be compliant with EN 60335-2-29. 6 General specifications 6.1 General requirements It shall be clearly apparent when the device is ready to accept a breath specimen. The device may have provision for manual acceptance of the test gas presented to it when conducting adjustment or calibrat
44、ion operations as well as metrological tests. Devices shall be provided with an indication when the internal power supply is becoming exhausted. If this low power indication is given, either the device stops operating or the device shall be capable of running further measurements according to the MP
45、Es. The battery warning indicator shall not lead to confusion with any other displayed function. Devices that also use external power supply shall be provided with an indicator that displays that power is on. This indicator shall not lead to confusion with any other displayed function. The means by
46、which the device is calibrated or adjusted shall only be accessible to authorised persons. General device functions shall be verified to ensure that the device performs in accordance with the manufacturers information. 6.2 Maximum permissible error (MPE) The maximum permissible error is 0,04 mg/L fo
47、r nominal alcohol concentration up to and including 0,20 mg/L. The maximum permissible error is 20 % of nominal alcohol concentration above 0,20 mg/L. 6.3 Measurement range Devices shall be capable of measuring alcohol concentrations according to the MPE in the range going from 0,00 to 0,50 mg/L. 6.
48、4 Operating environmental conditions Temperature: The devices shall be capable of use between + 10 C and + 40 C. If the manufacturer specifies that the device may be operated outside this range, then it shall fulfil the requirements of this standard for these conditions. If the device is operated ou
49、tside the temperature range, then this shall be indicated. BS EN 16280:2012EN 16280:2012 (E) 8 6.5 Ease of use The device shall be simple to use. Any influence by user errors on the result shall be eliminated. 6.6 Breath sampling method The device shall monitor the continuity of exhalation and the volume given in the time (duration) in order to identify an acceptable breath specimen for analysis. The de
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