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ISO 10993-10:2021
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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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International Organization for Standardization [iso]
