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| 医疗器械生物材料表征和化学性能检测的重要性 | |
| 引用本文： | 王春仁,奚廷斐,冯晓明. 医疗器械生物材料表征和化学性能检测的重要性[J]. 中国医疗器械信息, 2007, 13(5): 20-23 |
| 作者姓名： | 王春仁 奚廷斐 冯晓明 |
| 作者单位： | 中国药品生物制品检定所,北京,100050 |
| 摘 要： | 医疗器械生物学评价国际标准ISO10993第18和19部分作为医疗器械和生物材料生物学评价的重要组成部分越来越受到重视,在安全性评价中的重要一环就是材料的表征和材料中可萃取和迁移成分的鉴定。本文讨论那些试验可以满足这些要求。 |
| 关 键 词： | 医疗器械 生物材料 化学检测 评价 |
| 文章编号： | 1006-6586（2007）05-0020-04 |
| 修稿时间： | 2007-03-12 |
The Important Rule of Material and Chemical Characterization in Device Evaluation |
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| WANG Chun-ren,XI Ting-fei,FENG Xiao-ming. The Important Rule of Material and Chemical Characterization in Device Evaluation[J]. China Medical Devices Information, 2007, 13(5): 20-23 | |
| Authors: | WANG Chun-ren XI Ting-fei FENG Xiao-ming |
| Affiliation: | Beijing 100050 |
| Abstract: | Part 18 and 19 of ISO 10993,Biological Evaluation of Medical Devices,are receiving even more emphasis as they become an integral part of biological safety evaluation of biomaterials and medical devices.An important step in this process is the characterization of the material and identification of chemicals that migrate or extract from the polymer components.This article discuss which tests will meet the requirements |
| Keywords: | Medical Devices Biomaterials Characterization Evaluation |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |