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 EN IEC 60601-2-66:2020

Publication date:   Jun 16, 2020

General information

60.60 Standard published   Apr 3, 2020

CENELEC

CLC/SR 29 Electroacoustics

European Norm

11.180.15   Aids for deaf and hearing impaired people | 17.140.50   Electroacoustics

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-66:2015

NOW

PUBLISHED
EN IEC 60601-2-66:2020
60.60 Standard published
Apr 3, 2020

REVISED BY

IN_DEVELOPMENT
prEN IEC 60601-2-66