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.
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)
出处
《现代仪器与医疗》
CAS
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。
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
Medical electrical equipment
Electromagnetic compatibility
Equipment under test
Radio-frequency electromagnetic field radiation immunity
Uncertainty
Intermediate verification
