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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

Oct 16, 2019

General information

60.60     Oct 16, 2019

IEC

TC 29

International Standard

11.180.15     17.140.50  

English  

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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WITHDRAWN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