标准摘要
[中文适用范围]： ISO 10993 的这一部分规定了风险评估、危险识别测试选择和风险管理的策略，涉及因接触医疗器械而产生以下潜在不可逆生物效应的可能性： ——遗传毒性； ——致癌性； ——生殖和发育毒性。 当需要评估医疗器械的潜在遗传毒性、致癌性或生殖毒性时，ISO 10993 的这一部分适用。 注：ISO 10993-1 中提供了测试选择的指南。 [外文原描述]： ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
英文名称Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity