IEC 60601-2-66:2019《医用电气设备第2-66部分:助听器及助听器系统的基本安全和基本性能专用要求》标准难点分析和解读  

Analysis for the Difficult Clause of 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

作　　者：范庭波 江鑫 缪佳 FAN Ting-bo;JIANG Xin;MIAO Jia(Jiangsu Province for Medical Equipment Testing,Jiangsu Nanjing 210037)

机构地区：[1]江苏省医疗器械检验所,江苏南京210037

出　　处：《中国医疗器械信息》2022年第13期23-25,74,共4页China Medical Device Information

摘　　要：助听器作为一般在家庭护理环境中使用的医用电气设备,通用标准未能完全覆盖其风险。目前,IEC 60601-2-66为国际认可的助听器专用标准,但尚未转化为国内标准,文章就该标准的内容进行分析和梳理。Hearing aids are always used in the home healthcare environment.Hazards of hearing aids are not covered by general standard.Currently,as particular requirements of hearing aids,IEC 60601-2-66 is applied to hearing aids,however this standard has not been transformed.This article analyzes some of the clauses which are difficult to understand.

关 键 词：助听器 基本安全 

分 类 号：TH785[机械工程—仪器科学与技术]