<p>ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.</p>
<p>ISO 10993-10:2010 includes:</p>
<ul>
<li>pretest considerations for irritation, including <i>in silico</i> and <i>in vitro</i> methods for dermal exposure;</li>
<li>details of <i>in vivo</i> (irritation and sensitization) test procedures;</li>
<li>key factors for the interpretation of the results.</li>
</ul>
<p>Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.</p>
Registration number (WIID)
40884
Scope
<p>ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.</p>
<p>ISO 10993-10:2010 includes:</p>
<ul>
<li>pretest considerations for irritation, including <i>in silico</i> and <i>in vitro</i> methods for dermal exposure;</li>
<li>details of <i>in vivo</i> (irritation and sensitization) test procedures;</li>
<li>key factors for the interpretation of the results.</li>
</ul>
<p>Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.</p>
