Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

رقم المستند: NL ISO 10993 3 : 2009
القطاع: Health Care Technology
TC: NL TC 3001
ICS: 11.100.20
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.