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
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.
|Publication type||International Standard|
|TC/SC||TC 29 - Electroacousticsrss|
|ICS||11.180.15 - Aids for deaf and hearing impaired people|
17.140.50 - Electroacoustics
|File size||1564 KB|
The following test report forms are related:
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