EN 15964:2011
(Main)Breath alcohol test devices other than single use devices - Requirements and test methods
Breath alcohol test devices other than single use devices - 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 intended to be used for screening or preliminary testing. This standard specifies requirements for basic safety and performance, test methods and requirements for marking, labelling and operating instructions.
This standard gives guidelines for type approval procedure consisting of a number of technical performance tests, but excluding in vivo tests, that are carried out on devices supplied by the manufacturers.
In vivo tests, which are designed to test the ability of the device to work with real subjects, may be arranged in compliance with national requirements.
This standard is not applicable to devices covered by OIML R 126:1998 (Evidential breath analyzers) or single use testers.
Devices are designed for law enforcement.
Atemalkohol-Testgeräte zur Mehrfachverwendung - Anforderungen und Prüfverfahren
Diese Europäische Norm gilt für Atemalkohol-Testgeräte, mit denen die Konzentration an Alkohol gemessen
wird, die in einer Atemprobe enthalten ist, mit dem Zweck, eine Selektion oder Voruntersuchung durchzuführen.
In dieser Norm werden die Anforderungen an Betriebssicherheit und -verhalten, die Prüfverfahren
sowie die Anforderungen an Kennzeichnung, Beschriftung und Bedienungsanleitung festgelegt.
Diese Norm enthält Richtlinien für das Bauartzulassungsverfahren, das aus einer Anzahl an technischen
Prüfungen des Betriebsverhaltens besteht, wobei aber In-Vivo-Tests ausgeschlossen sind, die mit von den
Herstellern bereitgestellten Geräten durchgeführt werden.
In-Vivo-Tests, die dafür ausgelegt sind, die Eignung des Geräts für die Arbeit mit realen Personen zu prüfen,
dürfen in Übereinstimmung mit nationalen Anforderungen durchgeführt werden.
Diese Norm gilt nicht für Geräte, die in OIML R126:1998 (beweissichere Atemalkohol-Messgeräte) festgelegt
sind, oder für Atemalkohol-Testsysteme für den Einmalgebrauch.
Die Geräte sind für die Anwendung im Gesetzesvollzug ausgelegt.
Ethylotests, autres que les dispositifs à usage unique - 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 destinés à être utilisés pour des tests préliminaires ou de
dépistage. 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 la procédure d'approbation de type qui consiste en un
certain nombre d'essais de performance technique, à l'exclusion des essais in vivo, réalisés sur des dispositifs
fournis par les fabricants.
Les essais in vivo, qui sont conçus pour évaluer l'aptitude du dispositif à fonctionner sur des sujets réels,
peuvent être organisés conformément aux exigences nationales.
La présente norme n'est pas applicable aux dispositifs couverts par la recommandation R 126:1998 de l'OIML
(Éthylomètres), ni aux dispositifs à usage unique.
Les dispositifs sont destinés à être employés dans le cadre des dispositions législatives et réglementaires.
Preskusne naprave za merjenje alkohola v sapi (razen naprave za enkratno uporabo) - Zahteve in preskusne metode
Ta evropski standard velja za preskusne naprave za merjenje alkohola v sapi (razen naprav za enkratno uporabo), ki merijo koncentracijo alkohola v izdihanem vzorcu sape. Opredeljuje zahteve in preskusne metode, ki jim morajo ustrezati preskusne naprave za merjenje alkohola v sapi.
Tipski postopek odobritve je sestavljen iz številnih preskusov tehnične učinkovitosti, ki se izvajajo na napravah, ki jih dobavijo proizvajalci. Preskusi učinkovitosti so podrobno opisani v tem evropskem standardu.
General Information
Overview
EN 15964:2011 is the European Standard published by CEN that specifies requirements and test methods for breath alcohol test devices other than single‑use devices (multi‑use breathalysers) intended for screening or preliminary testing. The standard covers basic safety and performance, metrological testing procedures, marking, labelling and operating instructions, and provides guidelines for a type‑approval test programme carried out on devices supplied by manufacturers. It applies to devices designed for law enforcement, traffic‑safety and workplace screening, but excludes evidential analyzers covered by OIML R 126:1998 and single‑use testers.
Key topics and technical requirements
- Scope & exclusions: Applies to multi‑use screening devices; excludes single‑use testers and OIML R 126 evidential instruments.
- Safety requirements: Hygiene (single‑use mouthpieces), general and electrical safety for battery/charger systems.
- Metrological characteristics: Test methods for accuracy, repeatability, drift, and memory (hysteresis) using defined test gases and reference conditions.
- Maximum Permissible Error (MPE): Establishes MPE and procedures for verification and adjustment when devices fall outside limits (standard defines MPE but does not prescribe device‑specific numeric values in this summary).
- Influence factors & robustness: Tests for temperature, humidity, interfering substances, breath sampling parameters, voltage variation, and condensation/water vapour effects.
- Environmental and mechanical testing: Shock, vibration, climatic (cold, heat, damp heat), and electrical disturbances (electrostatic discharge, radiated RF immunity).
- Usability & performance: Requirements for measurement range, units and expression of results, start‑up time, power‑supply duration, data storage, and ease of use.
- Type‑approval guidance: Annexes provide example testing requirements, formulae and guidance on software validation and test procedures.
Practical applications - who uses EN 15964:2011
- Manufacturers of multi‑use breath alcohol testers for design verification and pre‑market testing.
- Accredited test laboratories performing type testing and metrological evaluations.
- Law enforcement and public safety procurement teams specifying device performance for roadside screening.
- Certification and conformity assessment bodies establishing type‑approval programs (excluding in vivo tests which remain subject to national rules).
- Regulators and workplace safety managers referencing minimum performance and labeling requirements for screening devices.
Related standards
- OIML R 126:1998 - Evidential breath analyzers (excluded from EN 15964 scope)
- Selected normative references cited in EN 15964: EN 60068 (environmental tests), EN 61000‑4‑2 / EN 61000‑4‑3 (EMC immunity), EN 60335‑2‑29 (battery charger safety) - used for specific test procedures.
EN 15964:2011 helps ensure that multi‑use screening breathalysers provide reliable, repeatable results suitable for preliminary testing in traffic and workplace safety contexts, and supports manufacturers and authorities in establishing consistent type‑approval and testing practices.
Frequently Asked Questions
EN 15964:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Breath alcohol test devices other than single use devices - Requirements and test methods". This standard covers: This European Standard applies to breath alcohol test devices which measure the concentration of alcohol contained in an exhaled breath sample intended to be used for screening or preliminary testing. This standard specifies requirements for basic safety and performance, test methods and requirements for marking, labelling and operating instructions. This standard gives guidelines for type approval procedure consisting of a number of technical performance tests, but excluding in vivo tests, that are carried out on devices supplied by the manufacturers. In vivo tests, which are designed to test the ability of the device to work with real subjects, may be arranged in compliance with national requirements. This standard is not applicable to devices covered by OIML R 126:1998 (Evidential breath analyzers) or single use testers. Devices are designed for law enforcement.
This European Standard applies to breath alcohol test devices which measure the concentration of alcohol contained in an exhaled breath sample intended to be used for screening or preliminary testing. This standard specifies requirements for basic safety and performance, test methods and requirements for marking, labelling and operating instructions. This standard gives guidelines for type approval procedure consisting of a number of technical performance tests, but excluding in vivo tests, that are carried out on devices supplied by the manufacturers. In vivo tests, which are designed to test the ability of the device to work with real subjects, may be arranged in compliance with national requirements. This standard is not applicable to devices covered by OIML R 126:1998 (Evidential breath analyzers) or single use testers. Devices are designed for law enforcement.
EN 15964:2011 is classified under the following ICS (International Classification for Standards) categories: 03.160 - Law. Administration; 71.040.40 - Chemical analysis. The ICS classification helps identify the subject area and facilitates finding related standards.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Preskusne naprave za merjenje alkohola v sapi (razen naprave za enkratno uporabo) - Zahteve in preskusne metodeAtemalkohol-testgeräte zur Mehrfachverwendung - Anforderungen und PrüfverfahrenEthylotests autres que les dispositifs à usage unique - Exigences et méthodes d'essaisBreath alcohol test devices other than single use devices - Requirements and test methods71.040.10Kemijski laboratoriji. Laboratorijska opremaChemical laboratories. Laboratory equipmentICS:Ta slovenski standard je istoveten z:EN 15964:2011SIST EN 15964:2011en,fr,de01-november-2011SIST EN 15964:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE 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 à usage unique - Exigences et méthodes d'essais
Atemalkohol-Testgeräte zur Mehrfachverwendung - Anforderungen und Prüfverfahren 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 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, 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
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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: ESIST EN 15964:2011
Example of type testing requirements . 25A.1Additional information for compliance testing. 25A.2Certification procedure . 25Annex B (informative)
Formula . 27Annex C (informative)
Simulated tetra immunity test . 28C.1Test procedure – General . 28C.2Test frequencies . 28C.3Test limits . 28C.4Modulation. 28Annex D (informative)
Software validation and verification . 30D.1General . 30D.2Security. 30Bibliography . 33 SIST EN 15964:2011
1) European standardization does not cover those subjects that clearly belong to the domain of regulation of the Member States unless this is explicitly supported by the national authority (i.e. regulatory measures remain the competence of the various Member States). SIST EN 15964:2011
Part 2-6: Tests
Test Fc: Vibration (sinusoidal) EN 60068-2-27, Environmental testing Part 2-27: Tests Test Ea and guidance: Shock EN 60068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle) EN 60068-2-32, Basic environmental testing procedures Part 2: Tests Test Ed: Free fall EN 60068-2-64, Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance EN 60068-2-78, Environmental testing Part 2-78: Tests Test Cab: Damp heat, steady state EN 60335-2-29, Household and similar electrical appliances Safety Part 2-29: Particular requirements for battery chargers EN 61000-4-2, Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test EN 61000-4-3, Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test SIST EN 15964:2011
Concentration in ethanol may be expressed in any other equivalent units, e.g. mg/L, 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 MPE
maximum permissible error extreme allowed value of measurement with respect to a test gas concentration defined in this standard 3.9 verification testing process to establish that the breath alcohol test device is operating within the limits of the defined MPE and repeatability 3.10 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 3.11 mouthpiece hygienically wrapped part intended for single use that is fitted to the breath alcohol test device through which the subject under test provides the breath specimen NOTE
A mouthpiece is used to prevent the breath sample being mixed with ambient air and diluting the alcohol concentration. SIST EN 15964:2011
In normal mode the specimen of breath shall be taken automatically after the requirements in 6.6 have been met. The device may have provision for manual acceptance of the vapour presented to it when conducting adjustment or verification 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, the device shall be capable of running at least ten further measurements. 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. SIST EN 15964:2011
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 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. SIST EN 15964:2011
For example, in case of lot by lot testing, the manufacturer shall perform the adjustment.
Perform the 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 shall 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 aspects 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 devices intended for use and without any additional protective means. SIST EN 15964:2011
± 0,1) L. If required by the test device, the test gas 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, 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 and 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. SIST EN 15964:2011
For accuracy, the following concentrations and number of measurements shall be used for the tests: Table 1 Concentration (mg/L) Number of measurements 0,00 10 0,10 20 0,25 20 0,40 20 0,60 10
If 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 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
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The standard EN 15964:2011 presents a comprehensive framework for breath alcohol test devices, specifically those that are not single-use and are intended for use in screening and preliminary testing. The scope of this standard is clearly defined, detailing the requirements for performance, basic safety, test methodologies, and operational instructions pertinent to these devices. One of the primary strengths of this standard is its focus on the technical performance tests that manufacturers must adhere to for type approval. This structured approach ensures that devices meet stringent safety and operational requirements prior to being utilized in law enforcement scenarios. Moreover, the exclusion of in vivo tests while allowing for their arrangement in compliance with national requirements provides flexibility, enabling authorities to tailor testing methods to their specific legal and operational contexts. Furthermore, the clarity in marking, labelling, and operational instructions outlined in the standard enhances the usability of these devices. By standardizing these elements, EN 15964:2011 aids in reducing confusion among users, thereby promoting effective and reliable use of breath alcohol test devices for law enforcement. Another notable aspect is the standard's explicit specification that it does not apply to evidential breath analyzers or single-use testers as per OIML R 126:1998. This delineation allows for a focused application of the standard, ensuring that it remains relevant only to the category of devices it is designed to regulate, thereby streamlining compliance and adherence to requirements for manufacturers and users alike. In summary, EN 15964:2011 stands out as a critical standard for breath alcohol test devices, reinforcing its relevance in enhancing the accuracy, safety, and operational efficacy of devices used in law enforcement settings. The comprehensive nature of its requirements and guidelines establishes a robust foundation for device manufacturers while ensuring that the devices used in screening scenarios comply with necessary standards.
EN 15964:2011標準は、呼気アルコールテストデバイスに関するものであり、その範囲は、息を吹きかけたサンプルに含まれるアルコール濃度を測定する装置に適用されます。この標準は、スクリーニングまたは予備テストを目的としたデバイスに特化しています。主な強みは、基本的な安全性と性能、テスト方法、そしてマーキング、ラベリング、操作指示に関する要件を明確に規定している点です。 また、EN 15964:2011は、製造業者が供給するデバイスに対して実施される一連の技術的性能テストに基づく型式承認手続きのガイドラインを提供していますが、実際の被験者を用いたin vivoテストは除外されています。これにより、基準が求める内容が明確化され、法執行機関向けに設計されたデバイスの信頼性を確保するのに寄与しています。 さらに、この標準は、OIML R 126:1998（証拠となる呼気分析器）や使い捨てテスト器には適用されないため、専用の基準を持つデバイスとの明確な区別を提供しています。これにより、呼気アルコールテストデバイスに特化した要件を設けることで、業界における整合性と信頼性が向上します。 EN 15964:2011は、呼気アルコール測定における技術的要件と性能を標準化することで、法執行機関の活動を支える重要な枠組みを提供しており、その重要性はますます高まっています。
표준 EN 15964:2011은 호흡 알코올 테스트 장치에 대한 요구 사항과 시험 방법을 규정하고 있으며, 주로 사용되는 장비의 기본 안전성과 성능, 표기 및 라벨링, 운영 지침과 관련된 요구 사항을 명확히 하고 있습니다. 이 표준은 일회용 장치를 제외한 호흡 알코올 테스트 장치에 적용되며, 주로 법 집행 기관에서 사용할 장비를 대상으로 합니다. 이 표준의 주요 강점 중 하나는 다양한 기술 성능 테스트를 포함하는 유형 승인 절차에 대한 가이드라인을 제공한다는 점입니다. 이를 통해 제조업체가 공급한 장치의 기능성이 검증되어 신뢰성을 높이는 데 기여합니다. 또한, 이 기준은 특정 국가의 요구 사항에 따라 실제 피험자를 대상으로 하는 인 비보 테스트를 별도로 수행할 수 있는 가능성을 제시하여, 장치의 실효성을 보강할 수 있는 구체적인 방법을 제공합니다. 이 표준은 OIML R 126:1998(증거 호흡 분석기) 또는 일회용 테스트 장치에 해당되지 않으므로, 이러한 장치와의 혼동을 방지하는 데에도 중요한 역할을 합니다. EN 15964:2011은 법 집행 기관에서 쉽게 사용할 수 있는 정확하고 안전한 장비를 제공하는 데 기여하며, 전반적으로 중요성을 지닌 유럽 표준이라 할 수 있습니다.
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