ISO 10993-10:2021
International Standard
Current Edition
·
Approved on
16 November 2021
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-10:2021 Files
English
48 Pages
Current Edition
BHD
82.59
ISO 10993-10:2021 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.
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