人工耳蜗植入系统的电磁兼容试验方法研究  

Research on Electromagnetic Compatibility Test Method of Cochlear Implant System

作　　者：刘美丽 张淑溢 朱成科 刘萌 杨姝 李庆雨 LIU Meili;ZHANG Shuyi;ZHU Chengke;LIU Meng;YANG Shu;LI Qingyu(EMC Evaluation Center,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250000,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院电磁兼容评价中心,山东济南250000

出　　处：《中国医疗设备》2023年第11期27-32,共6页China Medical Devices

基　　金：国家重点研发计划(2020YFC2007105)。

摘　　要：目的分析人工耳蜗植入系统的临床风险,研究相应的电磁兼容抗扰度安全性和有效性评价方法。方法结合人工耳蜗植入系统的工作原理,围绕运行模式、试验布置、试验程序、判定准则进行风险分析,并总结人工耳蜗植入系统的电磁兼容抗扰度评价要点,以及对试验的疑难点进行评估。结果通用标准YY 0505-2012、YY 9706.102-2021对人工耳蜗植入系统的非植入部分提出了静电放电及辐射抗扰度试验要求及方法,而YY 0989.7-2017对植入系统的电磁兼容性提出了更高要求。在对植入系统进行静电放电、非电离电磁辐射试验的基础上,建议对植入体增加静磁场试验项目,以进一步保证人工耳蜗植入系统在复杂电磁环境中使用的安全性和有效性。结论本文重点阐述基于风险分析的人工耳蜗植入系统电磁兼容抗扰度试验方法,并对日益复杂的电磁环境进行了分析,可为监管提供建议。Objective To analyze the clinical risks of cochlear implant systems,and study the corresponding safety and effectiveness evaluation methods of electromagnetic compatibility immunity.Methods Combined with the operating principle of cochlear implant system,the risk analysis was conducted around the operating mode,testing arrangement,testing procedure and judgment criteria,and the key points of electromagnetic compatibility immunity evaluation for cochlear implant systems were summarized,as well as the difficult points of the experiment were evaluated.Results General standards YY 0505-2012 and YY 9706.102-2021 set out requirements and methods for electrostatic discharge and radiation immunity test of non-implantable parts of cochlear implant systems,while YY 0989.7-2017 set higher requirements for electromagnetic compatibility of implant systems.On the basis of electrostatic discharge and non-ionizing electromagnetic radiation tests on the implant system,it was suggested to add static magnetic field tests to the implant to further ensure the safety and effectiveness of the cochlear implant system in the complex electromagnetic environment.Conclusion This paper focuses on the electromagnetic compatibility immunity test method of cochlear implant system based on risk analysis,and analyzes the increasingly complex electromagnetic environment,which can provide suggestions for supervision.

关 键 词：人工耳蜗 植入系统 电磁兼容 声音处理器 运行模式 

分 类 号：R197.39[医药卫生—卫生事业管理]