中国医疗设备2017，Vol.32Issue(4)：152-154,3.DOI:10.3969/j.issn.1674-1633.2017.04.042
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
庞雪莲 1张海明 2高山 2张赟 2周会林 3赵宏杰2
作者信息
- 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
- 折叠
摘要
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.关键词
IEC60601-2-10/YY0607-2007/神经和肌肉刺激器/输出闭锁Key words
IEC 60601-2-10/YY 0607-2007/nerve and muscle stimulators/output block分类
医药卫生引用本文复制引用
庞雪莲,张海明,高山,张赟,周会林,赵宏杰..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):152-154,3.
