DSF/ISO/DIS 10993-10
Biological evaluation of medical devices -- Part 10: Tests for skin sensitization
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| Organization: | DS |
| Status: | active |
| Page Count: | 60 |
| 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 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
February 14, 2023
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: – ...
DSF/ISO/DIS 10993-10
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: –...