EN 16280:2012

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 européenne 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 européenne 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 sont à afficher 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
• Publication Date: 09-Oct-2012
• ICS: 13.320 - Alarm and warning systems
• ICS: 71.040.40 - Chemical analysis
• Technical Committee: CEN/TC 367 - Project Committee - Breath-alcohol testers
• Drafting Committee: CEN/TC 367 - Project Committee - Breath-alcohol testers
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 03-Sep-2024
• Completion Date: 14-Apr-2025
• Ref Project: SIST EN 16280:2014 - Breath alcohol test devices for general public - Requirements and test methods

Overview

EN 16280:2012 (CEN) defines requirements and test methods for breath alcohol test devices intended as self-testers for the general public. It covers safety, performance, metrological tests, marking, labelling and operating instructions for electronic consumer breath testers (breathalyzers). The standard aims to help users get a reliable indication of breath alcohol concentration at the time of testing while preventing underestimation due to measurement uncertainty. It is not intended for evidential or professional breath analysers.

Key topics and technical requirements

• Scope: Devices that measure ethanol concentration in exhaled breath and are intended for general public self-testing.
• Measurement range: 0,00 to 0,50 mg/L (ethanol in breath).
• Maximum Permissible Error (MPE):
  • 0,04 mg/L for nominal concentrations ≤ 0,20 mg/L
  • 20 % of nominal concentration for values > 0,20 mg/L
• Sampling requirements:
  • Minimum breath volume: 1,2 L
  • Minimum flow rate: 0,15 L/s
  • Typical breath duration: 3–5 s
  • Maximum back pressure: 30 hPa at 0,2 L/s
  • Devices must monitor exhalation continuity and reject inadequate samples.
• Display and rounding:
  • Units: mg/L (or equivalent)
  • Test mode: results rounded to 0,01 mg/L
  • Normal mode: reported value rounded to 0,01 mg/L and increased by the MPE to avoid underestimation
  • Results above national limits must show an appropriate non‑numeric message (optional red “over limit” indicator).
• Safety and hygiene:
  • Individually sealed disposable mouthpieces; design to prevent cross‑contamination.
  • Electrical accessories (chargers) to comply with EN 60335‑2‑29.
• Metrological controls:
  • Calibration and adjustment procedures required; access restricted to authorised personnel.
  • Type‑testing and compliance tests described (informative Annex A).
• Environmental and durability tests: References to EN 60068 series (temperature, humidity, shock, etc.).

Applications and users

• Targeted at manufacturers, product designers, test labs, retailers and consumer safety organisations developing or certifying consumer breathalyzers.
• Useful for purchasers and fleet operators wishing to supply non‑evidential self‑test devices for preventive use (e.g., promoting road safety, workplace awareness).
• Not intended for legal evidential testing - do not substitute for professional OIML/EN‑certified evidential breath analysers.

Related standards

• OIML R 126:1998 - evidential breath alcohol analysers (not replaced by EN 16280)
• EN 15964 - professional breath alcohol test devices
• EN 60068 series - environmental testing
• EN 60335‑2‑29 - safety of battery chargers

Keywords: EN 16280:2012, breath alcohol test devices, breathalyzer, self tester, requirements and test methods, consumer breath tester, MPE, calibration, mouthpiece hygiene.

Standards Content (Sample)

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
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

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

(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

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

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

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
...