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IEC 60601-2-66:2019 ED3

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

Publication date:   Oct 16, 2019

General information

60.60 Standard published   Oct 16, 2019

IEC

TC 29

International Standard

11.180.15   Aids for deaf and hearing impaired people | 17.140.50   Electroacoustics

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
IEC 60601-2-66:2015 ED2

NOW

PUBLISHED
IEC 60601-2-66:2019 ED3
60.60 Standard published
Oct 16, 2019

REVISED BY

IN_DEVELOPMENT
IEC 60601-2-66 ED4