摘要
医疗器械故障术语库对器械风险管理具有重要的意义。ISO/TS 19218-1经ISO多次研究、讨论和修订10余年后问世,是目前国际上较为系统的器械故障术语标准。本文通过对ISO/TS 19218-1的制订背景、修订历程、结构、内容的介绍,以及与我国医疗器械故障术语库现状的比较,以期为我国器械故障术语库的建立提供参考。
Abstracts： The terminology database of medical device failure has the vital significance to the device risk management. Atier more than 10 years of research and being revised by the ISO,ISO/TS 19218-1 has come out as a current international systematic standard of device malfunction terminology. This paper introduced the formulation background, revision history, structure, content of ISO/TS 19218-1, as well as comparisons with the fact of our country, aiming to provide useful reference to establish Chinese terminology database of medical device failure.
出处
《中国药物警戒》
2013年第11期655-657,共3页
Chinese Journal of Pharmacovigilance
