标准摘要
[中文适用范围]： ISO 10993-3:2014 规定了风险评估和危害识别试验选择的策略，针对因接触医疗器械可能引发的以下潜在不可逆生物效应：基因毒性、致癌性、生殖和发育毒性。当已确定需要评估医疗器械的潜在基因毒性、致癌性或生殖毒性时，ISO 10993-3:2014 适用。 [外文原描述]： ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, 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: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity