EUROLAB laboratory provides testing and compliance services within the scope of EN 15964 standard. The EN 15964 standard applies to breath alcohol testers that measure the alcohol concentration in an exhaled breath sample intended for screening or pre-testing. This standard specifies essential safety and performance requirements, test methods, and requirements for marking, labeling and operating instructions.
This standard provides guidance for the type approval procedure, which consists of a series of technical performance tests, excluding in vivo tests performed on devices supplied by manufacturers. In vivo tests designed to test the device's ability to work with real subjects may be arranged in accordance with national requirements.
This standard is not applicable to devices covered by OIML R 126 (Evidual breath analyzers) or disposable test devices. The devices are designed for law enforcement.
Breath alcohol testers are widely used in professional applications such as law enforcement, promoting traffic safety and ensuring occupational safety in Europe. Test results can have serious consequences for everyone involved. Therefore, test results need to be reliable and acceptable.
This document contains a description of the minimum technical requirements that must be met for conformity testing of multi-use breath alcohol testers. It also includes details on compatibility testing and performance requirements for breath alcohol testers as a prerequisite for approval.
Reference may also be made to sections of this document for batch-by-batch testing. Any suitable technology capable of providing the desired functionality may be used in this document. The breath alcohol testers discussed in this standard use a mouthpiece to sample breath samples.
The device shall be designed to ensure the safety of the operator and the user of the device. Particular attention should be paid to the design and use of electrical connections, as well as to the materials chosen for mouthpiece construction and packaging.
The device should eliminate the possibility of breathing polluted air from previous users. The mouthpiece is for single use only. It should be possible to hold these mouthpieces in contact with the lips of the subject to be tested and without touching the part that has come into contact. Mouthpieces should be supplied in individual, easily-opened sealed packages.
It will be clearly visible when the device is ready to collect and analyze a breath sample. When the device is ready to accept a breath sample, no less than 3 minutes or no more than 10 minutes should be allowed to ensure a satisfactory sample, after which time the device may turn off automatically. The device must be switched off at any time.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
