| 从技术评价角度思考非生物型人工肝医用材料的特性 |
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| 引用本文： | 邓洁,张世庆,王永清.从技术评价角度思考非生物型人工肝医用材料的特性[J].透析与人工器官,2009,20(1):37-40. |
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| 作者姓名： | 邓洁 张世庆 王永清 |
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| 作者单位： | 国家食品药品监督管理局医疗器械技术审评中心,北京,100044 |
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| 摘 要： | 本文从技术评价角度阐述了现阶段非生物型人工肝医用材料特性研究的重点，论述了对非生物型人工肝医用材料技术审评的关注要点，提出了生物安全性评价中的几个现实性问题，以期共同探讨如何通过提高对非生物型人工肝医用材料技术评价以更好地推进非生物型人工肝医疗器械研发与评价的发展。
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| 关 键 词： | 人工肝 医用材料 评价 |
Characteristics for Biomaterials of Nonbiological Artificial Liver Based on the View of Technical Evaluation |
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| DENG Jie,ZHANG Shi-qing,WANG Yong-qing.Characteristics for Biomaterials of Nonbiological Artificial Liver Based on the View of Technical Evaluation[J].Chinese Journal of Dialysis and Artificial Organs,2009,20(1):37-40. |
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| Authors: | DENG Jie ZHANG Shi-qing WANG Yong-qing |
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| Institution: | ( Centre For Medical Device Evaluation ,SFDA ,Beijing 100044, China) |
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| Abstract: | This article discusses development research on biomaterials of nonbiological artificial liver based on the view of technical evaluation, and establishes evaluation requirements for biomaterials of nonbiological artificial liver. The common problems existed in registration and evaluations are also illustrated. Meanwhile, this article discusses how to promote the development and evaluation of medical devices in the research and technical evaluation, which is aimed to do some help on related researchers and manufacturers. |
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| Keywords: | artificial liver biomaterials evaluation |
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