新版IEC 60601-2-10与上一版本的主要变化及对神经和肌肉刺激器产品的影响  

Mainly Diversities Between the New Version and Previous Version of IEC 60601-2-10 and Effects on Nerve and Muscle Stimulators

作　　者：庞雪莲[1] 张海明[2] 高山[2] 张赟[2] 周会林 赵宏杰[2] PANG Xue-lian;ZHANG Hai-ming;GAO Shan;ZHANG Yun;ZHOU Hui-lin;ZHAO Hong-jie(Department of Electronic Technology,Tianjin Electronic Information College,Tianjin 300350, China;Tianjin Medical Device Quality Supervision and Testing Center, CFDA,Tianjin 300384, China;Shanghai Daosh Medical Technology Co., Ltd, Shanghai 201203, China)

机构地区：[1]天津电子信息职业技术学院电子技术系,天津300350 [2]天津市医疗器械质量监督检验中心,天津300384 [3]上海道生医疗科技有限公司,上海201203

出　　处：《中国医疗设备》2017年第4期152-154,共3页China Medical Devices

摘　　要：神经和肌肉刺激器在我国应符合YY 0607-2007行业标准。而YY 0607-2007转化自IEC60601-2-10:1987。IEC已经发布了新版IEC 60601-2-10:2016。本文介绍了新版本与上一版本在适用范围、术语和定义、输出、脉冲参数及电磁兼容性等方面的主要变化及对产品设计、外部标记、随机文件及注册审批等方面的可能影响,并对我国神经和肌肉刺激器类产品生产企业提升国际竞争力给出了加强参与国际标准化工作的建议。In China, nerve and muscle stimulators should comply with YY 0607-2007 standard,which is adopted from IEC 60601-2-10:1987. IEC/SC62D has published IEC 60601-2-10:2016 to replace IEC 60601-2-10:1987. This paper introduced the diversities between IEC 60601-2-10:2016 with IEC 60601-2-10:1987 in scope, terms and definitions, output marking, pulse parameters and electromagnetic compatibility, and possible impact on design, outer tag, random file and registration of the product. Finally, the suggestion that domestic nerve and muscle stimulators manufacturers should pay more attention to the international standardization to enhance the competitive has been made.

关 键 词：IEC60601-2-10 YY0607-2007 神经和肌肉刺激器 输出闭锁 

分 类 号：R197.3[医药卫生—卫生事业管理]