<p>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:</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)
55614
Scope
<p>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:</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>
