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.