| 我国医疗器械标准现状分析与建议 |
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| 引用本文： | 母瑞红,肖忆梅.我国医疗器械标准现状分析与建议[J].中国药事,2011,25(7):657-658. |
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| 作者姓名： | 母瑞红 肖忆梅 |
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| 作者单位： | 中国食品药品检定研究院国家食品药品监督管理局医疗器械标准管理中心,北京,100050 |
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| 摘 要： | 目的为我国医疗器械标准制修订工作提供参考。方法对我国医疗器械国家标准的采标情况、医疗器械标准类别的分布等现状进行分析研究。结果与结论应进一步加快医疗器械标准制修订工作,加大医疗器械标准的基础研究力度,重视医疗器械注册产品标准的管理和信息化建设。
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| 关 键 词： | 医疗器械 标准 标准分类 |
Analysis on the Current Situations of Medical Device Standards |
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| Mu Ruihong,Xiao Yimei.Analysis on the Current Situations of Medical Device Standards[J].Chinese Pharmaceutical Affairs,2011,25(7):657-658. |
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| Authors: | Mu Ruihong Xiao Yimei |
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| Institution: | Mu Ruihong and Xiao Yimei(National Institutes for Food and Drug Control,Beijing 100050) |
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| Abstract: | Objective To provide reference for standards development of medical devices.Methods The analysis was carried out on informations of the medical devices standards.Results and Conclusion A few suggestions were put forward for standards developed of medical devices. |
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| Keywords: | medical devices standards standards development |
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