ISO 10993-10:2021

OVERVIEW

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.

COMMENTS

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