摘要
为帮助体外诊断设备生产企业科学制定产品使用期限,结合国家药品监督管理局医疗器械技术审评中心发布的《有源医疗器械使用期限技术审查指导原则》,分析了可能影响体外诊断设备使用期限的主要因素,并重点举例介绍了一种体外诊断设备生化分析仪加速疲劳试验的评价方法,以期对相关产品生产企业科学评价和制定产品使用期限进行规范和指导。
In order to help the IVD medical equipment manufacturers to establish the service life of products scientifically,we analyze the main factors that may affect the service life of IVD medical equipment in accordance with the guiding principles for technical review of active medical devices issued by the center of medical device evaluation of NMPA,and focuse on an evaluation method of accelerated fatigue test,in order to standardize and guide the IVD medical equipment manufacturers to evaluate and formulate the product service life scientifically.
作者
牟鹏涛
张克
蒋硕
MOU Pengtao;ZHANG Ke;JIANG Shuo(Medical Electrical Equipment Inspection Department,Shandong Province Quality Inspection Center for Medical Devices,Ji'nan,250101)
出处
《中国医疗器械杂志》
2021年第5期555-558,共4页
Chinese Journal of Medical Instrumentation
关键词
体外诊断设备
使用期限
影响因素
评价
IVD medical equipment
service life
influence factor
evaluation
