基于YY9706.102-2021的射频辐射抗扰度试验及期间核查研究  

Test and intermediate checks analysis of radio-frequency electromagnetic field radiation immunity based on YY 9706.102-2021 standard

作　　者：刘法林 强小龙 秦秀娟 Liu Fain;Qiang Xiaoong;Qin Xiujuan(Guangxi Testing Center for Medical Devices,Nanning 530021,China)

机构地区：[1]广西壮族自治区医疗器械检测中心,南宁530021

出　　处：《现代仪器与医疗》2024年第5期30-34,共5页Modern Instruments & Medical Treatment

基　　金：广西壮族自治区食品药品监督管理局《2023年直属单位药品安全科研项目计划》桂药监办函[2023]284号,桂药监科直属[2023]004号。

摘　　要：在医疗器械射频辐射抗扰度测试过程中,若测试系统出现故障,可能会导致干扰信号未能有效施加于被测设备,从而产生“假阴性”结果。本文基于YY 9706.102-2021详细分析了射频辐射抗扰度的试验要求,通过测试过程中的不确定度分析以及期间核查研究,确保测试系统的可靠性和有效性。During the Radio-frequency electromagnetic field radiation immunity testing of medical devices,if a fault occurs in the test system,it may result in the failure to effectively apply interference signals to the medical electrical equipment,thus producing a“false negative”result.This paper analyzes the test requirements for Radio-frequency electromagnetic fi eld radiation immunity based on YY 9706.102-2021 in detail.By conducting an uncertainty analysis and an in-process verifi cation study during the testing process,this paper ensures the reliability and eff ectiveness of the test system.

关 键 词：医用电气设备 电磁兼容 被测设备 射频辐射抗扰度 不确定度 期间核查 

分 类 号：TH77[机械工程—仪器科学与技术] R197.39[机械工程—精密仪器及机械]