短波治疗设备关键参数检测方法的探讨  

Discussion on the Detection Methods of Key Parameters of Short-Wave Therapy Equipment

作　　者：邓振进 刘继广 白洁芳 吴碧涛 曹俐 DENG Zhenjin;LIU Jiguang;BAI Jiefang;WU Bitao;CAO Li(Hunan Testing Institute for Medical Devices,Changsha Hunan 410011,China;Reliability Testing Laboratory,National Engineering&Research Center for Medical Diagnostic Devices,Shenzhen Guangdong 518057,China;Henan Medical Device Inspection Institute,Zhengzhou Henan 450000,China)

机构地区：[1]湖南省医疗器械检验检测所,湖南长沙410011 [2]国家医用诊断仪器工程技术研究中心可靠性检测实验室,广东深圳518057 [3]河南省医疗器械检验所,河南郑州450000

出　　处：《中国医疗设备》2019年第9期35-37,共3页China Medical Devices

摘　　要：为规范短波治疗设备关键参数的检测方法,帮助设备生产企业及检测机构开展质量控制和检测,本文结合YY 91086-1999、YY 91087-1999、GB9706.1-2007、IEC 60601-2-3:2012+AMD1:2016 CSV等标准要求,介绍短波治疗设备关键参数的测试技巧和方法,并重点介绍试验时的注意事项。本文指明了短波治疗设备关键参数的正确测试方法,可避免检测错误并提高检测效率,保证设备上市前产品的安全有效,对规范和指导医疗器械的检测工作具有重要意义。In order to standardize the detection methods of key parameters of short-wave therapy equipment and help equipment manufacturers and testing institutions to carry out quality control and testing,we introduced the testing techniques and methods of the key parameters of the short-wave treatment equipment by combining the standard requirements of YY 91086-1999,YY 91087-1999,GB9706.1-2007 and IEC 60601-2-3:20+AMD1:2016 CSV and focused on the matters needing attention during the test in this paper.This paper points out the correct test methods for the key parameters of short-wave therapy equipment,which can avoid detection errors and improve detection efficiency,and ensure the safety and effectiveness of the products before the market of the equipment,which is of great significance to standardize and guide the detection of medical devices.

关 键 词：短波治疗设备 低功率设备 输出回路 应用器 器械检验 

分 类 号：R197.39[医药卫生—卫生事业管理]