中国药物警戒 ›› 2013, Vol. 10 ›› Issue (11): 655-657.

• 政策与法规研究 • 上一篇    下一篇

关于借鉴ISO/TS 19218-1建立我国医疗器械故障术语库的思考

李穗1,王刚2,钟玲3,董放2*   

  1. 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
  • 收稿日期:2013-07-17 修回日期:2016-03-09 出版日期:2013-11-08 发布日期:2016-03-09
  • 通讯作者: 董放,男,高级工程师,医疗器械不良事件监测与评价。E-mail:dongfang@cdr.gov.cn
  • 作者简介:李穗,女,药师,医疗器械不良事件监测与评价。

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

LI Sui1 ,WANG Gang2, ZHONG Ling3 ,DONG Fang2*   

  1. 1.Adverse Drug Reaction Monitoring Center of Jiangxi, Jiangxi Nanchang 330046, China;
    2.Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    3.Adverse Drug Reaction Monitoring Center of Chongqing, Chongqing 400014, China
  • Received:2013-07-17 Revised:2016-03-09 Online:2013-11-08 Published:2016-03-09

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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。

关键词: ISO/TS 19218-1, 医疗器械故障, 术语库, 风险管理

Abstract: The terminology database of medical device failure has the vital significance to the device risk management. After 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.

Key words: ISO/TS 19218-1, medical device failure, terminology database, risk management

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