关于借鉴ISO/TS 19218-1建立我国医疗器械故障术语库的思考  

Thoughts about Taking Reference of ISO/TS 19218-1 to Establish Medical Device Failure Terminology Database

作　　者：李穗 王刚[2] 钟玲 董放[2] 

机构地区：[1]江西省药品不良反应监测中心,江西南昌330046 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]重庆市药品不良反应监测中心,重庆400014

出　　处：《中国药物警戒》2013年第11期655-657,共3页Chinese Journal of Pharmacovigilance

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.

关 键 词：ISO TS 19218—1 医疗器械故障 术语库 风险管理 

分 类 号：R197.39[医药卫生—卫生事业管理]