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.
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)
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
关键词
助听器
基本安全
hearing aids
basic safety
