BS EN ISO 10993-10. Biological evaluation of medical devices Part 10. Tests for skin sensitization
|Standard number:||20/30377819 DC|
|Status:||Draft for Comment|
- 11.100.20 Biological evaluation of medical devices
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.
Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.