基于血液透析设备的故障模式、影响和危害性分析(FMECA)及相关失效数据分析  

Failure Mode,Effects and Criticality Analysis(FMECA)and Associated Failure Data Analysis Based on Hemodialysis Equipment

作　　者：林登焕 LIN Deng-huan(Medical Equipment Department,Hangzhou Hospital of Traditional Chinese Medicine,Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University,Zhejiang Hangzhou 310021)

机构地区：[1]杭州市中医院,浙江中医药大学附属杭州市中医院,杭州市丁桥医院(杭州市中医院丁桥分院)医学装备部,浙江杭州310021

出　　处：《中国医疗器械信息》2024年第23期169-172,共4页China Medical Device Information

摘　　要：我国医疗器械行业在近年来迅猛发展,对生产、经营、使用,均面临更高的要求。然而目前医疗器械的可靠性研究仍然处于起步阶段。文章以4008S V10血液透析设备为例,对其展开故障模式、影响及发生概率进行危害分析,得到尤其需要重视的6种故障。通过4个型号医疗器械在不同使用年限内出现故障的数据,进行统计分析,得出不同类型的医疗器械在其失效年限方面存在巨大差异。In China,medical device industry has developed rapidly in recent years,and it is facing higher requirements for production,management and use.However,the reliability research of medical devices is still in its infancy.Taking 4008S V10 hemodialysis machine as an example,this paper analyzes the failure mode,influence,occurrence probability and its hazard,and obtains 6 kinds of faults with special attention.Through the statistical analysis of the failure data of 4 models of medical devices in different service life,it is concluded that different types of medical devices have huge differences in their failure years.

关 键 词：故障模式 影响和危害性分析 血透透析设备 失效年限 

分 类 号：TH789[机械工程—仪器科学与技术]