CEN - EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Organization: | CEN |
Publication Date: | 1 February 2023 |
Status: | active |
Page Count: | 64 |
ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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.