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[资源] 材料生物相容性ISO10993标准体系简介

材料生物相容性评价标准，ISO10993体系介绍如下：

1.ISO 10993-1:2009 风险管理程序中的评价和测试
Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process

2.ISO 10993-2:2006 动物保护要求
Biological evaluation of medical devices Part 2: Animal welfare requirements

3.ISO 10993-3:2003 遗传毒性、致癌毒性和生殖毒性试验
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

4.ISO 10993-4:2002/Amd 1:2006 与血液相互作用试验选择
Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

5.ISO 10993-5:2009 体外细胞毒性试验
Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

6.ISO 10993-6:2007 植入后局部反应试验
Biological evaluation of medical devices Part 6: Tests for local effects after implantation

7.ISO 10993-7:2008 环氧乙烷残留限量
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

8.ISO 10993-8:2001 生物试验用参考材料的选择和条件
Biological evaluation of medical devices Part 8: Selection of reference materials

9.ISO 10993-9:1999 潜在降解产物定性与定量框架
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products

10.ISO 10993-10:2010 刺激和皮肤敏化试验
Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

11.ISO 10993-11:2006 全身毒性试验
Biological evaluation of medical devices Part 11: Tests for systemic toxicity

12.ISO 10993-12:2012 样品制备与参照样品
Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)

13.ISO 10993-13:1998 聚合物医疗器械的降解产物定性与定量分析
Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices

14.ISO 10993-14:2001 陶瓷降解产物定性与定量分析
Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics

15.ISO 10993-15:2000 金属与合金降解产物定性与定量分析
Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys

16.ISO 10993-16:1997 降解产物与可沥滤物毒性动力学研究设计
Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables

17.ISO 10993-17:2002 允许可沥滤物限制的建立
Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances

18.ISO 10993-18:2005 材料的化学特性
Biological evaluation of medical devices Part 18: Chemical characterization of materials

19.ISO/TS 10993-19:2006 材料的物理化学、形态学和地形学特征
Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials

20.ISO/TS 10993-20:2006 医疗器械的免疫毒性测试原则和方法
Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

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