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IEC 60601-2-66:2019 (EN-FR)

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

Standard Details

IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;
b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.

General Information

Status : ACTIVE
Standard Type: Main
Document No: IEC 60601-2-66:2019 (EN-FR)
Document Year: 2019
Pages: 115
Edition: 3.0
  • Section Volume:
  • TC 29 Electroacoustics

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IEC 60601-2-66:2019 (EN-FR)
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