| 欧盟医疗器械标准体系发展现状探析 |
| 投稿时间：2016-03-02 点此下载全文 |
| 引用本文：肖忆梅,欧阳昭连,白杨,等.欧盟医疗器械标准体系发展现状探析[J].医学信息学杂志,2016,37(11):66-69 |
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| 中文摘要:从标准化战略、法律法规、管理机制、运行监督及保障机制和具体的标准目录等方面，总结欧盟医疗器械标准体系的发展现状，以期对我国医疗器械标准研究有所启示。 |
| 中文关键词:欧盟 医疗器械 标准体系 现状 |
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| Exploration on the Development Status of Medical Device Standard System in EU |
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| Abstract:The paper summarizes the current development status of medical device standard system in European Union(EU) from the aspects of standardization strategy, laws and regulations, management, supervision and guarantee mechanism and specific standard catalogues, so as to provide references for medical device standard research in China. |
| keywords:European Union(EU) Medical device Standard system Current status |
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