<p>This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.</p>
<p>This document includes:</p>
<p>— details of in vivo skin sensitization test procedures;</p>
<p>— key factors for the interpretation of the results.</p>
<p>NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.</p>
Registration number (WIID)
75279
Scope
<p>This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.</p>
<p>This document includes:</p>
<p>— details of in vivo skin sensitization test procedures;</p>
<p>— key factors for the interpretation of the results.</p>
<p>NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.</p>
