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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

General information

Valid from 16.10.2019
ICS Groups
11.180.15 Aids for deaf and hearing impaired people 17.140.50 Electroacoustics
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.10.2019
Main
IEC 60601-2-66:2019
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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Amendment

EVS-EN 60601-2-37:2008/A1:2015

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Main

EVS-EN 61672-1:2013

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EVS-EN 60601-2-37:2008

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Newest version Valid from 07.03.2008
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EVS-EN 50332-1:2013

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Newest version Valid from 14.11.2013

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English