Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

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.