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SSH EN IEC 60601-2-66:2020

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

Mar 23, 2021

General information

60.60     Mar 23, 2021

95.99    Jun 4, 2025

DPS

DPS/KT 6

European Norm

11.180.15     17.140.50  

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<!-- NEW! -->IEC 60601-2-66:2019 is available as <a href="https://webstore.iec.ch/publication/65931">IEC 60601-2-66:2019 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.</br></br>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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized

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NOW

PUBLISHED
SSH EN IEC 60601-2-66:2020
60.60 Standard published
Mar 23, 2021

Related project

Adopted from EN IEC 60601-2-66:2020 IDENTICAL