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.
杨飞1，赵旭2，闫佩玉2，刘斌1，钟蕾1，刘东红1. 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.
YANG Fei1, ZHAO Xu2, YAN Peiyu2, LIU Bin1, ZHONG Lei1, LIU Donghong1. Example of Rectification for Intermediate Frequency Electrical Stimulators on the Electrcal
Safety and Electromagnetic Compatibility Tests. China Medical Devices, 2018, 33(3): 82-86.
