国产医用电气设备可靠性提高方法研究  

Exploration of Domestic Medical Electrical Equipment Reliability Promotion Method

作　　者：郁红漪 张鸣伟 张尉强 YU Hongyi;ZHANG Mingwei;ZHANG Weiqiang(Shanghai Testing and Inspection Institute for Medical Devices,Shanghai,201318)

机构地区：[1]上海市医疗器械检测所

出　　处：《中国医疗器械杂志》2019年第3期197-201,共5页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划项目(2018YFC0115800)

摘　　要：国产医疗器械可靠性已经是制约国产器械竞争力的主要因素之一,同时也是危及患者生命安全的重要因素和安全风险管理上的盲点。该文通过分析可靠性的核心要素和国内外医疗器械行业的情况,针对医疗器械行业医用电气设备在可靠性方面存在的问题进行了梳理分析,提出了提升国产医用电气设备可靠性的关键要点和需要解决的问题。The reliability of domestic medical equipment is one of the main factors that restrict the competitiveness of domestic medical devices.It is also an important factor that endangers the safety of patients and a blind spot in safety risk management.By analyzing the core elements of reliability and the situation of domestic medical device industry,this paper sorts out and analyzes the problems existing in the reliability of medical device industry,and puts forward the key points and problems to be solved to improve the reliability of domestic medical equipment products.

关 键 词：医用电器设备 可靠性 

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]