IEC 60601-2-66:2019 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

标准编号：IEC 60601-2-66:2019

中文名称：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

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

发布日期：2019-10-16

标准范围

IEC 60601-2-66:2019作为IEC 60601-2-66:2019 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-66:2019适用于助听器和助听器系统的基本安全，以下也称为ME设备或ME系统。IEC 60601-2-66:2019取消并取代2015年发布的第二版。它构成技术修订。与上一版相比，此版本包括以下重大技术变更:a)修订基本性能的定义；b)修订IEC 60601-1-2:20 14电磁干扰的应用；c)将助听器使用的电压从1.6 V校正到4.5 V；d)将跌落测试水平从1.5 m校正到1.0 m；e)更正IEC 60601-2-66:2015的措辞。

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

标准预览图