ISO 10993-3:2003 医疗装置生物学评定.第3部分：遗传毒性、致癌力和生殖毒性试验

标准编号：ISO 10993-3:2003

中文名称：医疗装置生物学评定.第3部分：遗传毒性、致癌力和生殖毒性试验

英文名称：Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

发布日期：2003-10

标准范围

ISO 10993-3:2003规定了医疗器械在以下生物学方面的危害识别和测试策略:遗传毒性、致癌性、生殖和发育毒性。ISO 10993-3:2003适用于已确定潜在遗传毒性、致癌性或生殖毒性的医疗器械的评估。ISO 10993-1中提供了试验选择指南。

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.Guidance on selection of tests is provided in ISO 10993-1.

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