| 浅谈医疗器械产品标准档案的建立 |
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| 引用本文： | 罗幼明,罗杜鹃. 浅谈医疗器械产品标准档案的建立[J]. 中国药事, 2009, 23(8): 780-782 |
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| 作者姓名： | 罗幼明 罗杜鹃 |
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| 作者单位： | 1. 湖北医疗器械质量检测中心,武汉,430077
2. 湖北省药品检验所 |
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| 摘 要： | 目的为完善医疗器械产品标准档案工作提供参考。方法对医疗器械标准从收集、建立到保管等档案管理工作提出了实际操作方法和建议。结果与结论医疗器械监管工作已步入科学、有序的轨道。医疗器械标准及其档案的建立是医疗器械监管工作的一部分。
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| 关 键 词： | 医疗器械 标准 档案 |
Discussion on Establishment of Product Standard Files of the Medical Device |
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| Luo Youming,Lou Dujuan. Discussion on Establishment of Product Standard Files of the Medical Device[J]. Chinese Pharmaceutical Affairs, 2009, 23(8): 780-782 |
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| Authors: | Luo Youming Lou Dujuan |
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| Affiliation: | Luo Youming and Lou Dujuan(Hubei Medical Device Quality Testing Center, Wuhan 430077; 1Hubei Province Institute for Drug Control) |
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| Abstract: | Objective The supervision work of medical device has entered the scientific and orderly track. Methods The establishment of standard file of medical device is a part of supervision work. Results and Conclusions To the medical device standard from the collection and establishment to records management work and so on the storage were proposed the actual operation method and the suggestion. |
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| Keywords: | medical device standard file establishment |
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