基于运维数据的医用电气设备使用故障时间数学分布研究与工程评估实践  

Research on Mathematical Distribution of Failure Time and Engineering Evaluation for Medical Electrical Equipment Based on Operation and Maintenance Data

作　　者：郁红漪 邹金林 张尉强 YU Hongyi;ZOU Jinlin;ZHANG Weiqiang(Shanghai Testing and Inspection Institute for Medical Devices,Shanghai,201318;Re-impro Technology LTD,Guangzhou,510610)

机构地区：[1]上海市医疗器械检测所,上海市201318 [2]广州然因普电子科技有限公司,广州市510610

出　　处：《中国医疗器械杂志》2020年第3期199-204,215,共7页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划项目(2018YFC0115800)。

摘　　要：论述了医用电气设备运维数据收集内容、方法和特征,以及使用故障时间分布模型的建立及评估方法。通过线性回归法和拟合优度检验,分别建立了医用电气设备三个层面的故障时间分布模型:一是设备级MTBF分布模型;二是关键部件不同故障模式的失效率分布模型;三是影响因素对关键部件故障模式的影响系数计算模型。该研究提出了MTBF分段模型建立的方法,实现了影响系数随时间变化的计算模型。This study mainly discusses the contents, methods and characteristics of the collection of operation and maintenance data, as well as the establishment and evaluation methods of the distribution model of the failure time of medical electrical equipment. The distribution models of failure time at three levels of medical electrical equipment are established by linear regression method and goodness of fit test: The first is the device level MTBF distribution model, the second is the failure rate distribution model of the failure mode of key components, the third is the calculation model of the influence coefficient of influence factor on the failure mode of key components. This study presents a method of establishing MTBF segment model and implements a calculation model of influence coefficient varying with time.

关 键 词：医用电气设备 运维数据 MTBF 线性回归法 威布尔分布 

分 类 号：R197.39[医药卫生—卫生事业管理]