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

BS EN 15964:2011

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 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

Contents 
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Type-testing
5 Safety
5.1 General comments
5.2 Hygiene
5.3 Electrical safety
6 General specifications
6.1 General requirements
6.2 Maximum permissible error (MPE)
6.3 Measurement range
6.4 Operating environmental conditions
6.4.1 Temperature
6.4.2 Humidity
6.5 Ease of use
6.6 Breath sampling method
6.7 Expression of results
6.7.1 Units of measurement
6.7.2 Rounding
6.7.3 Display
6.8 Adjustment
6.9 Start-up time
6.10 Frequency of measurement
6.11 Power supply duration
6.12 Data storage
6.13 General device functions
7 Metrological characteristics for testing
7.1 General conditions
7.2 Test gas characteristics
7.3 Reference conditions
7.4 Accuracy tests
7.4.1 General
7.4.2 Accuracy testing
7.4.3 Repeatability testing
7.4.4 Drift testing
7.5 Memory effects
7.5.1 Hysteresis
7.5.2 Effect of water vapour (condensation)
7.6 Influence factors
7.6.1 General
7.6.2 Operating temperature
7.6.3 Ambient relative humidity
7.6.4 Interfering substances
7.6.5 Influence factors exhalation parameters
7.6.6 Voltage variation (internal battery)
7.6.7 Power supply duration tests
7.7 Mechanical and climatic disturbances
7.7.1 General
7.7.2 Shock & vibration
7.7.3 Climatic environment
7.8 Electrical disturbances
7.8.1 General
7.8.2 Electrostatic discharge
7.8.3 Immunity to radiated electric fields
8 Marking
9 Operating instructions
Annex A (informative) Example of type testing requirements
A.1 Additional information for compliance
A.2 Certification procedure
Annex B (informative) Formula
Annex C (informative) Simulated tetra immunity test
C.1 Test procedure – General
C.2 Test frequencies
C.3 Test limits
C.4 Modulation
Annex D (informative) Software validation and verification
D.1 General
D.2 Security
Bibliography

This standard BS EN 15964:2011 Breath alcohol test devices other than single use devices. Requirements and test methods is classified in these ICS categories:

• 03.160 Law. Administration
• 13.320 Alarm and warning systems
• 71.040.40 Chemical analysis