1.Department of Electronic Technology,
Tianjin Electronic Information College,
Tianjin 300350, China; 2.Tianjin Medical
Device Quality Supervision
and Testing
Center, CFDA,Tianjin 300384, China;
3.Shanghai Daosh Medical Technology
Co., Ltd, Shanghai 201203, China
Abstract：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.
庞雪莲1，张海明2，高山2，张赟2，周会林3，赵宏杰2. 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[J]. 中国医疗设备, 2017, 32(4): 152-154.
PANG Xue-lian1, ZHANG Hai-ming2, GAO Shan2, ZHANG Yun2, ZHOU Hui-lin3, ZHAO Hong-jie2. Mainly Diversities Between the New Version and Previous Version of IEC
60601-2-10 and Effects on Nerve and Muscle Stimulators. China Medical Devices, 2017, 32(4): 152-154.
