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.

Edition	2021
Standard Part No	10
Published Date	2021
Published By	International Standardization Organisation
Page Count	48