YY/T 0316(ISO 14971)标准实施方法研究《医疗器械-风险管理在医疗器械中的应用》

中国医疗器械信息 Pub Date : 2012-01-01 DOI:10.3403/30200974

Qian-qian Xu

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引用次数: 143

摘要

本文简要介绍了医疗器械风险管理和《YY/T 0316医疗器械风险管理在医疗器械中的应用》标准的发展历程。通过对医疗器械风险管理相关文献的研究和标准问卷调查，了解了国内外医疗器械风险管理标准的应用现状。然后分析了标准实施中存在的问题，最后针对这些问题提出了实施途径和建议，以加快标准的实施。

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Study on Implementation Approach for Standard YY/T 0316(ISO 14971) "Medical Devices-Application of Risk Management to Medical Devices"

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.

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来源期刊

中国医疗器械信息

自引率

0.00%

发文量

15598

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.