IEC 60601-2-66:2019

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

OVERVIEW

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.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2019
No. of Pages 115
ICS Classification 17.140.50 Electroacoustics
11.180.15 Aids for deaf and hearing impaired people
Committee TC 29
Available for Purchase For sale in Singapore only
Adoption IEC