<p>This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.</p>
<p>This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.</p>
<p>Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. </p>
<p>Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. </p>
<p>Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.</p>
Registration number (WIID)
33364
Scope
<p>This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.</p>
<p>This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.</p>
<p>Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. </p>
<p>Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. </p>
<p>Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.</p>
