标准编号：ISO/TR 10993-33:2015
中文名称：医疗装置生物学评定 第33部分：基因毒性测试评估指南 对ISO10993-3的补充
英文名称：Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
发布日期：2015-03
标准范围
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: — genotoxicity, — carcinogenicity, and — reproductive and developmental toxicity. This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. NOTE Guidance on selection of tests is provided in ISO 10993-1.
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