ISO-10993-10 › Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
. details of in vivo skin sensitization test procedures;
. key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
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