naSRPS EN IEC 60645-7:2024

Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials

Scope

IEC 60645-7:2025 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or vibratory stimuli of short duration. This document defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instruments (screening and diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration used with auditory evoked potential equipment and other equipment (e.g. otoacoustic emission instruments), and methods for their measurement.
The purpose of this document is to ensure that measurements made under comparable test conditions with different instruments complying with this document will be consistent. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.
Evoked response measurement using the application of electric stimuli to a subject is beyond the scope of this document.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.