BS EN IEC 60645-6:2022 PDF

Scope: 1 Scope This part of IEC 60645 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli. This document defines the characteristics to be specified by the manufacturer, specifies minimum mandatory functions for two types of instruments and provides performance specifications applicable to both instrument types. This document describes methods to be used to demonstrate conformance with the specifications in this document and guidance on methods for periodic calibration. 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. Instruments can provide a measurement function not specifically within the scope of this document and still comply with the relevant requirements of this document for the functions that are within the scope. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.

BS EN IEC 60645-6:2022 Referenced Document

IEC 60318-4 Electroacoustics - Simulators of human head and ear - Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts
IEC 60318-5 Electroacoustics - Simulators of human head and ear - Part 5: 2 cm<(hoch)3> coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts
IEC 60601-1 Medical electrical equipment - ALL PARTS
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-22 Update
IEC 60645-1:2017 Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
IEC 60645-3:2020 Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
ISO/IEC Guide 98-3 Uncertainty of measurement - Guide to the expression of uncertainty in measurement (GUM:1995). Extension to any number of output quantities

2022 BS EN IEC 60645-6:2022 Electroacoustics. Audiometric equipment. Instruments for the measurement of otoacoustic emissions