Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (11): 655-657.

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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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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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