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immediate downloadReleased: 2020-11-12
BS EN IEC 60601-2-66:2020 - TC
Tracked Changes. Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
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Standard number: | BS EN IEC 60601-2-66:2020 - TC |
Released: | 2020-11-12 |
ISBN: | 978 0 539 14956 2 |
Status: | Tracked Changes |
DESCRIPTION
BS EN IEC 60601-2-66:2020 - TC
This standard BS EN IEC 60601-2-66:2020 - TC Tracked Changes. Medical electrical equipment is classified in these ICS categories:
- 11.180.15 Aids for deaf and hearing impaired people
- 17.140.50 Electroacoustics
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.