| GHTF建议的体外诊断医疗器械分类和评价的原则 |
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| 引用本文： | 李爽,陈宝爱,彭子明.GHTF建议的体外诊断医疗器械分类和评价的原则[J].中国医疗器械杂志,2009,33(6):438-440. |
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| 作者姓名： | 李爽 陈宝爱 彭子明 |
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| 作者单位： | 1. 上海理工大学医疗器械与食品学院,上海市,200093
2. 上海双吉医疗器械研究所,上海市,200093 |
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| 摘 要： | 体外诊断（IVD）医疗器械正在迅速发展，品种日益增多。文中简要介绍了GHIF（全球协医调作组）建议的关于IVD医疗器械的分类和符合性评价原则。
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| 关 键 词： | 体外诊断医疗器械 分类 符合性评价 |
The Proposed Principles by GHTF of the Classification and Assessment for in Vitro Diagnostic(IVD)Medical Devices |
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| LI Shuang,CHEN Bao-ai,PENG Zi-ming.The Proposed Principles by GHTF of the Classification and Assessment for in Vitro Diagnostic(IVD)Medical Devices[J].Chinese Journal of Medical Instrumentation,2009,33(6):438-440. |
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| Authors: | LI Shuang CHEN Bao-ai PENG Zi-ming |
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| Institution: | LI Shuang, CHEN Bao-ai, PENG Zi-ming(1 School of medical Instrument and food engineering, University of Shanghai for Science and Technology, Shanghai, 200093 2 Shanghai ShuangJi Medical Device Institute, Shanghai, 200093) |
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| Abstract: | The IVD（In Vitro Diagnostic）Medical Devices are various and develop rapidly. This paper introduces briefly the principles of classification and conformity assessment for IVD medical that proposed by GHTF （Global Harmonization Task Force）. |
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| Keywords: | IVD medical devices classification conformity assessment |
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