摘要
该研究结合上海市第六人民医院在用医用X射线计算机体层成像(简称CT)的临床使用数据,将其转化为产品可靠性指标需求,并分别以机械类代表性部件——检查床(以下简称“病床”)和电子类代表性部件——DCB(数据控制板)为例,结合其失效特点与临床使用数据的关系,探讨研究了其从可靠性指标需求到可靠性设计与验证的一整套闭环实现方法。
Based on the clinical application data of medical X-ray computed tomography(CT)in the Shanghai Sixth People's Hospital,this study transformed it into the product reliability index requirements,and took the mechanical representative component—examination table(hereinafter referred to as"patient table")and the electronic representative component—DCB(data control board)as examples.Based on the relationship between failure characteristics and clinical application data,a complete set of closedloop implementation methods from reliability index requirements to reliability design and verification are discussed.
作者
贾东方
金玮
张尉强
刘义红
贺飞
邹金林
JIA Dongfang;JIN Wei;ZHANG Weiqiang;LIU Yihong;HE Fei;ZOU Jinlin(Shanghai United Imaging Healthcare Co.Ltd.,Shanghai,201800;Shanghai Sixth People’s Hospital,Shanghai,200233;Shanghai Institute of Medical Device Testing,Shanghai,201318;Re-impro Technology Ltd.,Guangzhou,510610)
出处
《中国医疗器械杂志》
2021年第3期261-265,共5页
Chinese Journal of Medical Instrumentation
基金
国家重点研发计划(2018YFC0115804)。
