<p>This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.</p>
<p>This document includes:</p>
<p>— pre-test considerations for irritation, including <em>in silico</em> and <em>in vitro</em> methods for dermal exposure;</p>
<p>— details of <em>in vitro</em> and <em>in vivo</em> irritation test procedures;</p>
<p>— key factors for the interpretation of the results.</p>
Registration number (WIID)
93388
Scope
<p>This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.</p>
<p>This document includes:</p>
<p>— pre-test considerations for irritation, including <em>in silico</em> and <em>in vitro</em> methods for dermal exposure;</p>
<p>— details of <em>in vitro</em> and <em>in vivo</em> irritation test procedures;</p>
<p>— key factors for the interpretation of the results.</p>
