摘要
通过分析国产大型有源医疗器械PET/CT的组成和各子系统特点,针对PET/CT 10年使用期限的指标要求,研究其使用期限的评价方法。首先介绍使用期限的概念,提出以整机系统分解为子系统/部件的评价技术思路;然后在此基础上,分解分析影响PET/CT使用期限的关键子系统/部件,研究各子系统/部件的可靠性指标评价方法,分析评价相关子系统/部件的可靠性指标;最后以这些子系统/部件的可靠性指标数据为基础,综合分析评价PET/CT整机的使用期限。
In this study,through the analysis of the composition of domestic large radioactive medical equipment PET/CT and the characteristics of each subsystem,combing the vulnerable spots,according to the standard requirements of PET/CT for 10 years in its service life,we research the PET/CT service life's effectiveness.Firstly,this study introduces the concept of service life,the relationship between service life and risk analysis,the pivotal system composition of PET/CT,the importance of reliability of each component,the traditional test method to verify its reliability is researched.This study suggests a test procedure and method to prove the reliability of various components of PET/CT equipment during the service life.This method is described in detail,and the specific test process in practical engineering application is discussed,which proves that it is beneficial to ensure the effectiveness of PET/CT during the service life.
作者
李楠
鲁文涛
张尉强
邹金林
LI Nan;LU Wentao;ZHANG Weiqiang;ZOU Jinlin(Neusoft Medical Systems Co.Ltd.,Shenyang,110167;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256-260,共5页
Chinese Journal of Medical Instrumentation
基金
国家重点研发项目(2018YFC0115800)。
