Breath alcohol test devices for general public - Requirements and test methods

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 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 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 in 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 measurement.

Atemalkoholtestgeräte für den allgemeinen Gebrauch - Anforderungen und Prüfungen

Diese Europäische Norm gilt für Atemalkoholtestgeräte, mit denen die in einer exhalierten Atemprobe ent-haltene Alkoholkonzentration gemessen wird, konstruiert und vorgesehen für die Anwendung als Selbst-testgerät für die breite Öffentlichkeit. Das Atemalkoholtestgerät soll zum Zeitpunkt des Tests eine verlässliche Anzeige der Atemalkoholkonzentration liefern.
In dieser Europäischen Norm werden die Anforderungen an Betriebssicherheit und  verhalten, die Prüfverfahren sowie die Anforderungen an Aufschriften, Kennzeichnungen und Bedienungsanleitungen festgelegt.
Diese Europäische Norm beinhaltet Leitlinien zur Durchführung von Prüfungen, die die Einhaltung der Anforderungen bestätigen sollen und die aus einer Reihe von technischen Leistungsprüfungen bestehen.
Es ist nicht beabsichtigt, dass die Messergebnisse dieser Geräte dazu verwendet werden sollten, die Er-gebnisse von beweiskräftigen Atemalkoholmessgeräten, die nach OIML R 126:1998 arbeiten, oder von Atemalkoholtestgeräten für professionelle Anwendungen zu entkräften, die nach EN 15964 oder vergleich-baren nationalen Vorschriften arbeiten.
Deshalb sind die Messergebnisse auf solche Weise anzuzeigen, dass der Anwender, soweit möglich, vor einer Unterschätzung seiner Atemalkoholkonzentration geschützt wird. Solch eine Unterschätzung kann durch Messunsicherheiten verursacht werden, mit der jede Messung behaftet ist.

Ethylotests pour le grand public - Exigences et méthodes d'essais

La présente Norme européenne s'applique aux éthylotests qui mesurent la concentration d'alcool contenu dans un échantillon d'air expiré, et qui sont conçus et destinés à être utilisés comme un dispositif d'auto vérification par le grand public et qui fournissent une indication fiable de la concentration en alcool dans l'air expiré au moment du test.
La présente norme spécifie les exigences fondamentales de sécurité et de performance, les méthodes d'essai ainsi que les exigences relatives au marquage, à l'étiquetage et à la notice d'utilisation.
La présente norme donne des lignes directrices pour les procédures d'essais de conformité qui consistent en un certain nombre d'essais de performance technique.
Il n'est pas prévu que les résultats obtenus à l'aide de ces dispositifs soient utilisés pour réfuter les résultats obtenus à l'aide d'éthylomètres couverts par la recommandation R 126:1998 de l’OIML ou d'éthylotests utilisés dans des applications professionnelles couverts par l'EN 15964 ou des réglementations nationales similaires.
Par conséquent, les résultats des mesures doivent être affichés de manière à empêcher, autant que possible, l'utilisateur de sous-estimer sa concentration d'alcool du fait des incertitudes de mesure intrinsèques à chaque mesurage.

Naprave za preskušanje alkoholiziranosti za splošno uporabo - Zahteve in preskusne metode

General Information

Status
Published
Public Enquiry End Date
24-Sep-2011
Publication Date
12-Feb-2014
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
10-Jan-2014
Due Date
17-Mar-2014
Completion Date
13-Feb-2014

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Naprave za preskušanje alkoholiziranosti za splošno uporabo - Zahteve in preskusne metodeAtemalkoholtestgeräte für den allgemeinen Gebrauch - Anforderungen und PrüfungenEthylotests pour le grand public

- Exigences et méthodes d'essaisBreath alcohol test devices for general public - Requirements and test methods71.040.10Kemijski laboratoriji. Laboratorijska opremaChemical laboratories. Laboratory equipment13.200NDWDVWURIAccident and disaster controlICS:Ta slovenski standard je istoveten z:EN 16280:2012SIST EN 16280:2014en,fr,de01-marec-2014SIST EN 16280:2014SLOVENSKI

STANDARD
SIST EN 16280:2014
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE 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 - Exigences et méthodes d'essais

Atemalkoholtestgeräte für 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 national 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 version 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, Czech 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.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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: ESIST EN 16280:2014

EN 16280:2012 (E) 2 Contents Page Foreword ..............................................................................................................................................................3Introduction .........................................................................................................................................................41Scope ......................................................................................................................................................52Normative references ............................................................................................................................53Terms and definitions ...........................................................................................................................54Type-testing ............................................................................................................................................65Safety ......................................................................................................................................................65.1General comments.................................................................................................................................65.2Hygiene ...................................................................................................................................................75.3Electrical safety......................................................................................................................................76General specifications ..........................................................................................................................76.1General requirements ............................................................................................................................76.2Maximum permissible error (MPE).......................................................................................................76.3Measurement range ...............................................................................................................................76.4Operating environmental conditions ...................................................................................................76.5Ease of use .............................................................................................................................................86.6Breath sampling method .......................................................................................................................86.7Expression of results ............................................................................................................................86.8Adjustment .............................................................................................................................................96.9Calibration period ..................................................................................................................................96.10Start-up time ...........................................................................................................................................96.11Time for accepting a specimen ............................................................................................................96.12Frequency of measurement ..................................................................................................................96.13Power supply duration ....................................................................................................................... 107Metrological characteristics for testing ........................................................................................... 107.1General conditions ............................................................................................................................. 107.2Test gas characteristics ..................................................................................................................... 107.3Reference conditions ......................................................................................................................... 117.4Accuracy tests .................................................................................................................................... 117.5Memory effect ...................................................................................................................................... 127.6Influence factors ................................................................................................................................. 127.7Mechanical and climatic disturbances ............................................................................................. 148Marking ................................................................................................................................................ 169Operating instructions ....................................................................................................................... 16Annex A (informative)

Example of type testing requirements ..................................................................... 18A.1Additional information for compliance testing ................................................................................ 18A.2Certification 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 ..................................................................................................................................................... 22 SIST EN 16280:2014

EN 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 an 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 held 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, 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 the United Kingdom. SIST EN 16280:2014

EN 16280:2012 (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 educating 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 out 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 requirements in this standard apply for electronic devices only. SIST EN 16280:2014

EN 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 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 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 in 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 measurement. 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 (including 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 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 this 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 it is able to take a breath specimen and determine the alcohol level in that breath specimen SIST EN 16280:2014

EN 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 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 in ethanol may be expressed in any other equivalent units, e.g. µg/L or µg/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 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 test 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 device 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 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. SIST EN 16280:2014

EN 16280:2012 (E) 7 5.2 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 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 device 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 calibration 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 MPEs. 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 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 manufacturer's information. 6.2 Maximum permissible error (MPE) The maximum permissible error is 0,04 mg/L for 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.

6.4 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 outside the temperature range, then this shall be indicated. SIST EN 16280:2014

EN 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 device shall give a signal if the acceptable volume is not achieved and shall terminate the test procedure at that point, after which the device may reset automatically and indicate readiness to accept a further attempt.

For a device, in its normal sampling configuration, the back pressure, volume, flow rate and duration required to collect a satisfactory breath specimen shall comply with the following:  minimum volume = 1,2 L;  minimum flowrate = 0,15 L/s;  maximum back pressure = 30 hPa at a flowrate of 0,2 L/s;  minimum duration = 3 to 5 s. 6.7 Expression of results

6.7.1 Units of measurement The units of measurement shall be mg/L or equivalent unit (cf.3.6).

6.7.2 Rounding in test mode In test mode, the device shall display the analytical result of each test rounded to the nearest 0,01 mg/L or equivalent unit. 6.7.3 Rounding in normal mode In normal mode, the reported result shall be rounded to the nearest 0,01 mg/L or equivalent unit analytical result, increased by the MPEs at the level of the analytical result.

6.7.4 Display

For all devices, the reported results shall be limited to a maximum value according to the measurement range (0,50 mg/L). In normal mode, it shall not be possible to read out the numerical value of a particular result that is either over a national limit or over range.

The reported result of the measurement of the alcohol content of the breath specimen shall be displayed in one of the following ways:  Format 1): the alcohol concentration is expressed as a numerical value (numerical format) up to a national limit, in particular a drink driving limit. For any reported results above the national limit, the display shall indicate an appropriate message (not a numerical result) which should not be confused with any other message. Additionally, besides displaying the appropriate message, the device may have a red light only indicating the “over limit” message which should not be confused with any other light. For reported results less than or equal to the MPEs, the display shall indicate 0,00 mg/L.  Format 2): the alcohol concentration is expressed as a numerical value (numerical format). Above the measurement range, the display shall indicate an over range message (not a numerical result) which SIST EN 16280:2014

EN 16280:2012 (E) 9 should not be confused with any other message. For reported results less than or equal to the MPEs, the display shall indicate 0,00 mg/L. An example for both formats is given in Annex B. The display shall permit easy reading of the reported result in all levels of ambient light (for example, indirect bright sunlight and in the dark). The reported result shall be displayed for at least 10 s.

The device shall have an easy means for the testing laboratories to show the conversion from the analytical result to the reported result (see 6.7.3) and from numerical values to message displayed (Format 1)).

The units of measurement shall be displayed in the vicinity of the result. 6.8 Adjustment The device shall have the means for adjusting the results of measurement of the device to an alcohol standard. The procedure and equipment shall be specified by the manufacturer. 6.9 Calibration period The result of the measurement shall be stable for at least 6 months (cf. 7.4.3). The manufacturer may stipulate a longer period of stability but no more than one (1) year. If a maximum number of measurements within this period is given additionally by the manufacturer, the breath tester shall have:  either a visible counter;  or a masked counter which is supplemented by a feature indicating clearly that the maximum number of measurements is reached. If this number of tests is reached before the period of stability has expired, then the device shall prevent further measurements until it has been calibrated. The expiration of calibration per

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