IEC 60601-2-66:2019 PRV 
Pre release version

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

English/French
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Abstract

This Final Draft International Standard is an up to 6 weeks' pre-release of the official publication. It is available for sale during its voting period: 2019-06-14 to 2019-07-26. By purchasing this FDIS now, you will automatically receive, in addition, the final publication.

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 60601-2-66:2019cancels 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.

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Additional information

Publication typeInternational Standard
Publication date2019-06-14
Edition3.0
Available language(s)English/French
TC/SCTC 29 - Electroacousticsrss
ICS11.180.15 - Aids for deaf and hearing impaired people
17.140.50 - Electroacoustics
Stability date  2022
Pages114
File size1564 KB

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