Breath alcohol test devices other than single use devices - Requirements and test methods

This European Standard applies to breath-alcohol testers, other than single use devices, which measure the concentration of alcohol contained in an exhaled breath sample. It defines the requirements and test methods to which breath alcohol testers shall comply.
The type approval procedure consists of a number of technical performance tests that are carried out on devices supplied by the manufacturers. The performance tests are detailed in this European Standard.

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 ouverts par la recommandation R126:1998 de l'OIML, ni aux dispositifs à usage unique.
Les dispositifs sont destinés à être employés dans le cadre de l'application de la loi.

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

Status
Published
Public Enquiry End Date
04-Oct-2009
Publication Date
03-Oct-2011
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
16-Sep-2011
Due Date
21-Nov-2011
Completion Date
04-Oct-2011

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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
SIST EN 15964:2011
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

EN 15964:2011 (E) 2 Contents Page Foreword ..............................................................................................................................................................4Introduction .........................................................................................................................................................51Scope ......................................................................................................................................................62Normative references ............................................................................................................................63Terms and definitions ...........................................................................................................................74Type-testing ............................................................................................................................................85Safety ......................................................................................................................................................85.1General comments.................................................................................................................................85.2Hygiene ...................................................................................................................................................85.3Electrical safety......................................................................................................................................86General specifications ..........................................................................................................................86.1General requirements ............................................................................................................................86.2Maximum permissible error (MPE).......................................................................................................96.3Measurement range ...............................................................................................................................96.4Operating environmental conditions ...................................................................................................96.4.1Temperature ...........................................................................................................................................96.4.2Humidity ..................................................................................................................................................96.5Ease of use .............................................................................................................................................96.6Breath sampling method .......................................................................................................................96.7Expression of results ............................................................................................................................96.7.1Units of measurement ...........................................................................................................................96.7.2Rounding ............................................................................................................................................. 106.7.3Display ................................................................................................................................................. 106.8Adjustment .......................................................................................................................................... 106.9Start-up time ........................................................................................................................................ 106.10Frequency of measurement ............................................................................................................... 106.11Power supply duration ....................................................................................................................... 116.12Data storage ........................................................................................................................................ 116.13General device functions ................................................................................................................... 117Metrological characteristics for testing ........................................................................................... 117.1General conditions ............................................................................................................................. 117.2Test gas characteristics ..................................................................................................................... 127.3Reference conditions ......................................................................................................................... 127.4Accuracy tests .................................................................................................................................... 127.4.1General ................................................................................................................................................. 127.4.2Accuracy testing ................................................................................................................................. 137.4.3Repeatability testing ........................................................................................................................... 137.4.4Drift testing .......................................................................................................................................... 137.5Memory effects .................................................................................................................................... 147.5.1Hysteresis ............................................................................................................................................ 147.5.2Effect of water vapour (condensation) ............................................................................................. 147.6Influence factors ................................................................................................................................. 147.6.1General ................................................................................................................................................. 147.6.2Operating temperature ....................................................................................................................... 147.6.3Ambient relative humidity .................................................................................................................. 157.6.4Interfering substances ....................................................................................................................... 157.6.5Influence factors exhalation parameters .......................................................................................... 167.6.6Voltage variation (internal battery) ................................................................................................... 18SIST EN 15964:2011

EN 15964:2011 (E) 3 7.6.7Power supply duration tests .............................................................................................................. 187.7Mechanical and climatic disturbances .............................................................................................. 197.7.1General ................................................................................................................................................. 197.7.2Shock & vibration ................................................................................................................................ 197.7.3Climatic environment .......................................................................................................................... 207.8Electrical disturbances ....................................................................................................................... 217.8.1General ................................................................................................................................................. 217.8.2Electrostatic discharge ....................................................................................................................... 227.8.3Immunity to radiated electric fields ................................................................................................... 228Marking ................................................................................................................................................. 239Operating instructions ........................................................................................................................ 23Annex A (informative)

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

EN 15964:2011 (E) 4 Foreword This document (EN 15964:2011) 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 September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. 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 organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 15964:2011

EN 15964:2011 (E) 5 Introduction Breath alcohol test devices are widely used in Europe in professional applications like law enforcement, promotion of traffic safety and work safety. Test results may lead to severe consequences for everybody involved. Therefore, the test results need to be reliable and acceptable. This document contains a description of the minimum technical requirements to be met for compliance testing of multi-use breath alcohol test devices. It contains also details concerning the compliance testing and performance requirements of breath alcohol test devices as a prerequisite for approval 1). References may also be made to sections of this document for lot-by-lot testing. Any appropriate technology capable of providing the functionality required in this document may be used. Breath alcohol test devices considered in this standard use mouthpieces for sampling the breath specimens.

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

EN 15964:2011 (E) 6 1 Scope 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. 2 Normative references The following referenced documents are indispensable for the application of this document. 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 EN 60068-2-2, Environmental testing  Part 2-2: Tests  Test B: Dry heat EN 60068-2-6, Environmental testing 

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

EN 15964:2011 (E) 7 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 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 NOTE e.g. Pass or Fail 3.5 test mode mode in which the device displays the result of a test gas specified in this standard in numerical format 3.6 unit of measurement concentration of ethanol expressed in milligrams of ethanol per litre of exhaled volume NOTE

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

EN 15964:2011 (E) 8 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 to ensure the safety of the operator and 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. 5.2 Hygiene The device shall preclude the possibility of inhaling contaminated air from previous users. The mouthpiece is intended for single use only. It shall be possible to handle these mouthpieces without touching the part which will be and which has been in contact with the lips of the person being tested. 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 the EN 60335-2-29 standard. 6 General specifications 6.1 General requirements It shall be clearly apparent when the device is ready to take and analyse a breath specimen. When the device is ready to accept a breath specimen a period of not less than 3 minutes or greater than 10 minutes shall be allowed for a satisfactory specimen to be provided after which time the device may automatically switch off. It shall be possible to switch off the device at any time.

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

EN 15964:2011 (E) 9 6.2 Maximum permissible error (MPE) The maximum permissible error is +/-0,02 mg/L for alcohol concentrations up to and including 0,20 mg/L. The maximum permissible error is ± 10 % of nominal concentration for alcohol concentration above 0,20 mg/L. 6.3 Measurement range Devices shall be capable of measuring alcohol concentrations in the range 0,00 mg/L to 2,00 mg/L. 6.4 Operating environmental conditions 6.4.1 Temperature The devices shall be capable of use between – 5 °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 specified range, then it may indicate that it cannot take a sample. 6.4.2 Humidity The devices shall be capable of use up to 93 % RH. 6.5 Ease of use In normal mode, the device shall not be influenced in its operation by user error. 6.6 Breath sampling method The device shall monitor the continuity of exhalation and the volume given 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. Manufacturers may at their discretion set a limit for the number of attempts to provide a breath specimen for analysis from any one subject. For a device, the pressure, volume and flowrate required to collect a satisfactory breath specimen shall comply with the following absolute values:  minimum volume = 1,2 L;  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 of measurement In test mode the units of measurement shall be mg/L or equivalent unit. SIST EN 15964:2011

EN 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 test 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 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 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 reading 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 display 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 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 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

EN 15964:2011 (E) 11 6.11 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 permanent 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 if 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 manufacturer's information. 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 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

EN 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 least 90 %. The carrier gas shall have 5 % of CO2 (volumetric fractions). If the influence of 5 % of CO2 is 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 carrier gas shall reflect the O2 concentration 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 The reference conditions defined for the tests are as follows:  Temperature: ambient temperature: (22 ± 4) °C;  humid

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