| 医疗器械标准档案的建立与管理实践 |
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| 引用本文： | 邵玉波,苑富强,刘艳珍,李佳戈,任海萍. 医疗器械标准档案的建立与管理实践[J]. 中国医疗器械信息, 2013, 0(7): 53-55,60 |
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| 作者姓名： | 邵玉波 苑富强 刘艳珍 李佳戈 任海萍 |
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| 作者单位： | 中国食品药品检定研究院,北京100050 |
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| 摘 要： | 阐述了医疗器械标准档案管理的重要性,介绍了医疗器械标准档案的建立过程和方法,以及对所建标准档案进行规范化、信息化管理的实践经验,为促进实验室顺利通过认可,推进实验室持续发展、不断改进提供参考。
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| 关 键 词： | 医疗器械 标准档案 档案管理 |
Practice about the Standard Archives Establishment and Management of the Medical Device |
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| SHAO Yu-bo,YUAN Fu-qiang,LIU Yan-zhen,LI Jia-ge,REN Hai-ping. Practice about the Standard Archives Establishment and Management of the Medical Device[J]. China Medical Devices Information, 2013, 0(7): 53-55,60 |
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| Authors: | SHAO Yu-bo YUAN Fu-qiang LIU Yan-zhen LI Jia-ge REN Hai-ping |
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| Affiliation: | National Institutes for Food and Drug Control (Beijing 100050) |
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| Abstract: | This paper expounded the importance of the standard archives of medical device, while the establishment method and management practice of standard archives was introduced as well, to provide reference for the fob of sustainable development. |
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| Keywords: | medical device standard archives archives management |
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