DS/ISO 10993-10
Biological evaluation of medical devices – Part 10: Tests for skin sensitization
| Organization: | DS |
| Publication Date: | 14 February 2023 |
| Status: | active |
| Page Count: | 56 |
| 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.
Document History