ISO 10993-3:2014规定了风险评估，危害识别测试和风险管理选择方面的策略，涉及由于接触医疗器械而产生的以下潜在的不可逆的生物效应: 遗传毒性; 致癌性; 生殖发育毒性。 ISO 10993-3:2014适用于对潜在遗传毒性，致癌性或生殖毒性评估医疗器械的需求

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.