ISO10993生物相容性测试如何办理

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**
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





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