scope:

Specifies the general requirements for hearing aids and specifies the tolerances on measured electroacoustic performance characteristics, but does not give requirements for electroacoustic performance, in order to provide one method of showing conformity with the Medical Devices Directive 93/42/EEC. General requirements include a minimum set of performance data and the method of measurement, electrical safety, electromagnetic compatibility, biological effects of materials used, labelling, marking and user instruction.