| 医疗器械免疫毒理学试验和评价 |
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| 引用本文： | 王春仁,奚廷斐. 医疗器械免疫毒理学试验和评价[J]. 中国医疗器械信息, 2007, 13(4): 22-25 |
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| 作者姓名： | 王春仁 奚廷斐 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 摘 要： | 本文介绍了医疗器械免疫毒理学的最新进展和基本要求,主要介绍了免疫毒理学的概念、免疫毒理学试验流程、医疗器械免疫毒性的效应、免疫毒性效应的免疫反应类型、免疫毒性反应的试验模型和方法,为医疗器械生物材料的免疫毒理学评价提供了基本的原则和方法。
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| 关 键 词： | 医疗器械 免疫毒理学 生物学评价 |
| 文章编号： | 1006-6586（2007）04-0022-04 |
| 修稿时间： | 2007-01-17 |
The Immunotoxicity Testing and Evaluation of the Medical Devices |
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| WANG Chun-ren,XI Ting-fei. The Immunotoxicity Testing and Evaluation of the Medical Devices[J]. China Medical Devices Information, 2007, 13(4): 22-25 |
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| Authors: | WANG Chun-ren XI Ting-fei |
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| Affiliation: | Beijing 100050 |
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| Abstract: | This paper reviewed the recent progress and requirement of the immunotoxicity of the medical devices. Especially presented a detailed introduction of the immunotoxicity definition, flow chart of the immunotoxicity testing, potential immunological effects of devices and constitute materials, classification of immune response associated with potential immunotoxic effects and examples of tests, indicators and models for the evaluation of immune response on the medical devices. |
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| Keywords: | Medical Devices Immunotoxicity Biological Evaluation |
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