Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
医用电气设备第2-66部分:助听器和助听器系统基本安全和基本性能的特殊要求
IEC 60601-2-66:2019 RLV contains both the official IEC International Standard and its Redline version. The Redline version is not an official document, it is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.
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.