中国医疗设备2018，Vol.33Issue(3)：82-86,5.DOI:10.3969/j.issn.1674-1633.2018.03.021
中频电疗仪电气安全及电磁兼容整改实例
Example of Rectification for Intermediate Frequency Electrical Stimulators on the Electrcal Safety and Electromagnetic Compatibility Tests
摘要
Abstract
Objective To improve the security, the post-market medical devices to ensure the safety of using machinery, the electrical safety and electromagnetic compatibility performance of 13 medium frequency electrotherapy instrument production enterprise in Beijing city were detected, the risk and influence factors in design and production of medium frequency electrotherapy apparatus was analyzed, and the corresponding risk control suggestions was put forward. Methods The research was mianly performed in the form of instrument detection. In addition, we visited production enterprises and proposed technical improvement suggestions. Finally, we re-checked the effects of the rectification. Results Totally 13 test reports and 12 re-test reports were collected. The technology of medium frequency electrotherapy apparatus in Beijing was preliminarily understood. Conclusion Technical improvements were performed on the electrical safety and electromagnetic compatibility. The qualified rate was improved from 7.69% to 75.00% which was more than 10 times, and the safety of intermediate frequency electrotherapy was greatly improved.关键词
中频电疗仪/生产企业/电气安全/电磁兼容Key words
intermediate frequency electrical stimulator/production company/electrical safety/electrical electromagnetic compatibility分类
医药卫生引用本文复制引用
杨飞,赵旭,闫佩玉,刘斌,钟蕾,刘东红..中频电疗仪电气安全及电磁兼容整改实例[J].中国医疗设备,2018,33(3):82-86,5.基金项目
北京市科学技术委员会2013年第一批绿色通道项目(Z131100005613032). （Z131100005613032）
