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EVS-EN IEC 60601-2-66:2020

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

General information
Valid from 15.04.2020
Base Documents
IEC 60601-2-66:2019; EN IEC 60601-2-66:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.04.2020
Main
05.01.2016
Main
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.
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Standard monitoring
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IEC TR 62809:2019

Summary of requirements and tests to products in the scope of IEC 60601-2-66
Newest version Valid from 22.10.2019