Project No.ISO/DIS 10993-3
Title<p>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:</p> <ul> <li>genotoxicity;</li> <li>carcinogenicity;</li> <li>reproductive and developmental toxicity.</li> </ul> <p>ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.</p>
Registration number (WIID)88199
Scope<p>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:</p> <ul> <li>genotoxicity;</li> <li>carcinogenicity;</li> <li>reproductive and developmental toxicity.</li> </ul> <p>ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.</p>
StatusAptauja
ICS group11.100.20