从检验的视角对医疗器械电磁兼容性能探究  

Explored the Function of Electromagnetic Compatibility(EMC) of Medical Devices from the Perspective of Test

作　　者：高之鹏 徐默达 张伟 刘艳灵 曹相军 何浩星 GAO Zhipeng;XU Moda;ZHANG Wei;LIU Yanling;CAO Xiangjun;HE Haoxing(Henan Institute for Drug and Medical Device Inspection,Zhengzhou,450018)

机构地区：[1]河南省药品医疗器械检验院,郑州市450018

出　　处：《中国医疗器械杂志》2023年第4期442-444,453,共4页Chinese Journal of Medical Instrumentation

摘　　要：目的 提高医疗器械电磁兼容的质量,提升其通过电磁兼容测试的效率,进而推动其上市审批速度。方法 统计分析近年医疗器械电磁兼容测试项目不合格情况,从检验的视角分析医疗器械电磁兼容通过率低的原因。结果 根据分析原因,从医疗器械厂商和检验机构这两个角度给出了建议。结论 为了确保医疗器械电磁兼容质量,医疗器械厂商、监管部门和检验检测机构应该加大对医疗器械电磁兼容性监管力度和评价研究,确保产品的安全性,携手推动医疗器械产业健康有序发展。Objective To improve the electromagnetic compatibility(EMC) quality of medical devices,improve the efficiency of EMC testing,and promote the speed of market approval.Methods The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed,and the reasons of low EMC quality of medical devices were analyzed from the perspective of test.Results Based on the analysis of the reasons,the suggestions were given from the perspectives of medical device manufacturers and testing organizations.Conclusion In order to ensure the quality of EMC of medical devices,medical device manufacturers,regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility,to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.

关 键 词：医疗器械 电磁兼容 检测机构 监管部门 

分 类 号：R955[医药卫生—药学] TH77[机械工程—仪器科学与技术]