<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses:</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the database of reference chemical skin sensitizers and non-skin sensitizers;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>reference materials;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>feasibility testing of candidate test methods, including any method optimization for use with extracts of medical devices;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>prevalidation of candidate test methods;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the interlaboratory study:</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>sample preparation and coding;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>spiking of the extracts from the negative control medical device material;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>data collection;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>statistical analysis to assess reliability and reproducibility.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The use of the approaches described in this document to assess the applicability of a candidate test method does not imply that the candidate test method can be used as a stand-alone test for evaluating the skin sensitization potential of medical devices. For certain candidate test methods, integrated approaches and/or defined approaches are needed.<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext;">1</span></span>]</sup> The evaluation of skin sensitization potential of a medical device is described in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">10993</span></span>-</span><span class="stddocPartNumber"><span lang="EN-GB" style="color: black; mso-color-alt: windowtext;">10</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">.</span></p>
Registration number (WIID)
83916
Scope
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses:</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the database of reference chemical skin sensitizers and non-skin sensitizers;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>reference materials;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>feasibility testing of candidate test methods, including any method optimization for use with extracts of medical devices;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>prevalidation of candidate test methods;</span></p>
<p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>the interlaboratory study:</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>sample preparation and coding;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>spiking of the extracts from the negative control medical device material;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>data collection;</span></p>
<p class="MsoListContinue2" style="tab-stops: 19.85pt 40.0pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>statistical analysis to assess reliability and reproducibility.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The use of the approaches described in this document to assess the applicability of a candidate test method does not imply that the candidate test method can be used as a stand-alone test for evaluating the skin sensitization potential of medical devices. For certain candidate test methods, integrated approaches and/or defined approaches are needed.<sup>[<span class="citebib"><span style="color: black; mso-color-alt: windowtext;">1</span></span>]</sup> The evaluation of skin sensitization potential of a medical device is described in <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext;">ISO</span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext;">10993</span></span>-</span><span class="stddocPartNumber"><span lang="EN-GB" style="color: black; mso-color-alt: windowtext;">10</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">.</span></p>
