{"title":"Study on Implementation Approach for Standard YY/T 0316(ISO 14971) \"Medical Devices-Application of Risk Management to Medical Devices\"","authors":"Qian-qian Xu","doi":"10.3403/30200974","DOIUrl":null,"url":null,"abstract":"This thesis briefly introduced the risk management of medical devices and the development history of the standard \"YY/T 0316 Medical devices-Application of risk management to medical devices\".Through research on related literatures and standard questionnaire survey on medical devices’risk management,we knew the application status of risk management standard in medical devices home and abroad.Then we analyzed some problems in implementation of the standard,and at last we proposed the implementation approach and some suggestions to these problems to accelerate the implementation of the standard.","PeriodicalId":9853,"journal":{"name":"中国医疗器械信息","volume":"8 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"143","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械信息","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3403/30200974","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 143
Abstract
This thesis briefly introduced the risk management of medical devices and the development history of the standard "YY/T 0316 Medical devices-Application of risk management to medical devices".Through research on related literatures and standard questionnaire survey on medical devices’risk management,we knew the application status of risk management standard in medical devices home and abroad.Then we analyzed some problems in implementation of the standard,and at last we proposed the implementation approach and some suggestions to these problems to accelerate the implementation of the standard.
期刊介绍：
China Medical Device Information is an academic journal organized by the China Medical Device Industry Association, which mainly publishes original research papers, reviews and commentaries in this field.
Columns: Essay, Review, Clinical Medical Engineering, Clinical Application Research, Equipment Management and Medical Informatization
China Medical Device Information, founded in 1995, has been included in well-known databases such as KnowledgeNet (in) and Wipro (in), and is one of the national key academic journals under the supervision of the State Drug Administration.
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