高频手术设备双极高频漏电流检测方法探讨  

Detection method of bipolar HF leakage current in HF surgical equipment

作　　者：曾安妮 杜秋楠 侯建勋 ZENG An-ni;DU Qiu-nan;HOU Jian-xun(Shenzhen Institute for Drug Control(Shenzhen Testing Center of Medical Devices),Shenzhen 518057,Guangdong Province,China;Key Laboratory of Intelligent Medical Device Research and Evaluation of Guangdong Medical Products Administration,Shenzhen 518057,Guangdong Province,China;Shenzhen Academy of Metrology&Quality Inspection,Shenzhen 518057,Guangdong Province,China)

机构地区：[1]深圳市药品检验研究院(深圳市医疗器械检测中心),广东深圳518057 [2]广东省药品监督管理局智能化医疗器械研究与评价重点实验室,广东深圳518057 [3]深圳市计量质量检测研究院,广东深圳518057

出　　处：《医疗卫生装备》2024年第4期88-92,共5页Chinese Medical Equipment Journal

基　　金：国家重点研发计划项目(2021YFF0602904)。

摘　　要：依据GB 9706.202—2021《医用电气设备第2-2部分:高频手术设备及高频附件的基本安全和基本性能专用要求》中的测试方法,采用不同设备和不同连接方式的组合,分别对2台高频手术设备进行了双极高频漏电流检测,指出了高频分析仪仅作为测试电阻和/或电流表接入电路时测量结果是相对准确的,为高频手术设备双极高频漏电流检测提供了参考。Bipolar HF leakage current testing was carried out for two pieces of HF surgical equipment respectively by using a combination of different equipment and different connection methods according to the test method in GB 9706.202—2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.It's pointed out relatively accurate measurements could be obtained when the HF analyzer was accessed to the circuit only as a test resistor and/or ammeter.References were provided for bipolar HF leakage current detection in HF surgical equipment.

关 键 词：高频手术设备 双极 高频漏电流 高频分析仪 漏电流检测 

分 类 号：R318.6[医药卫生—生物医学工程] TH772[医药卫生—基础医学]