超声诊断设备在GB 9706.1-2020检验中应关注的要点分析  

Analysis of Key Points Should be Paid Attention in GB 9706.1-2020 Inspection of Ultrasonic Diagnostic Equipment

作　　者：裴晓娟 张克 田佳 季升林 郝鹏飞 PEI Xiaojuan;ZHANG Ke;TIAN Jia;JI Shenglin;HAO Pengfei(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101

出　　处：《中国医疗设备》2024年第7期107-110,123,共5页China Medical Devices

基　　金：山东省重点研发计划(2020CXGC010501)。

摘　　要：本文从整体上对比了GB 9706.1-2020与GB 9706.1-2007的差异,并结合超声诊断设备的特点,分析了风险管理活动应关注的风险点,阐述了制定基本性能的参考依据和验证基本性能的特定试验,比较了患者漏电流和总患者漏电流测量时的区别,详述了换能器组件进行电介质强度试验前的特殊处理,解析了电池安全的检测要点,概述了可用性工程过程和应关注的重点,对超声诊断设备的设计、生产和管理提供指导和借鉴。This paper compared the differences between GB 9706.1-2020 and GB 9706.1-2007 as a whole,and taking ultrasonic diagnostic equipment as an example,analyzed the risk points that should be paid attention to in risk management activities,expounded the reference basis for formulating basic performance and the specific tests to verify basic performance,compared the difference between the measurement of patient leakage current and total patient leakage current,described the special treatment of transducer assembly before dielectric strength test,analyzed the key points of battery safety detection,and summarized the usability engineering process and the key points that should be paid attention.This paper provides guidance and reference for the design,production and management of ultrasonic diagnostic equipment.

关 键 词：风险管理 基本性能 电击防护 可用性工程过程 超声诊断设备 

分 类 号：R197.39[医药卫生—卫生事业管理]