医疗器械电磁兼容检测风险研究  

Research on the Risk of Electromagnetic Compatibility Testing for Medical Devices

作　　者：杨成乐 陈朋刚 刘斌 杨鹏强 徐静娴 YANG Cheng-le;CHEN Peng-gang;LIU Bin;YANG Peng-qiang;XU Jing-xian(Gansu Provincial Institute of Equipment Inspection and Testing,Gansu Lanzhou 730000)

机构地区：[1]甘肃省医疗器械检验检测所,甘肃兰州730000

出　　处：《中国医疗器械信息》2025年第3期32-36,共5页China Medical Device Information

摘　　要：随着医疗器械生产及研发技术的快速发展,其产品电磁兼容性问题日益凸显。电磁兼容检测是为了确保医疗器械在复杂的电磁环境中安全、有效的运行。然而,在实施电磁兼容检测的过程中存在多种潜在的风险,可能会影响检测结果的准确性、可靠性和确定性。文章旨在系统地分析医疗器械电磁兼容检测中的风险因素,并提出相应的风险管理策略和对策。文章介绍了医疗器械电磁兼容检验检测的基本概念、现用检测技术以及国内外现状研究;着重从检测设备、检测环境和检验人员的技能三个方面深入剖析了存在的风险,构建了风险评估模型,并采用定量方法对风险因素进行量化与评价;此外,基于大量案例分析研究验证了风险评估模型的有效性,并提出了针对风险管理的解决措施。研究结果表明,通过实施综合的风险管理策略,可以显著降低电磁兼容检测过程中的风险,提高医疗器械的安全性能。未来的研究应进一步探索更高效的风险评估方法和风险管理工具,以适应不断变化的技术环境和市场需求。With the rapid development of medical device production and research and development technology,the issue of electromagnetic compatibility(EMC)of its products is becoming increasingly prominent.Electromagnetic compatibility testing is to ensure the safe and effective operation of medical devices in complex electromagnetic environments.However,there are various potential risks in the implementation of electromagnetic compatibility testing,which may affect the accuracy,reliability,and certainty of the testing results.This article aims to systematically analyze the risk factors in electromagnetic compatibility testing of medical devices and propose corresponding risk management strategies and countermeasures.Firstly,this article introduces the basic concepts of electromagnetic compatibility testing for medical devices,current testing techniques,and current research status both domestically and internationally.Secondly,the existing risks were analyzed in depth from three aspects:detection equipment,detection environment,and the skills of inspection personnel.Then,a risk assessment model was constructed and quantitative methods were used to quantify and evaluate risk factors.Finally,based on a large number of cases,the effectiveness of the risk assessment model was analyzed and verified,and solutions for risk management were proposed.The research results of this article indicate that implementing comprehensive risk management strategies can significantly reduce the risks in the electromagnetic compatibility testing process and improve the safety performance of medical devices.Future research should further explore more efficient risk assessment methods and risk management tools to adapt to the constantly changing technological environment and market demands.

关 键 词：医疗器械 电磁兼容 检测风险 风险管理 案例分析 

分 类 号：TH772[机械工程—仪器科学与技术]