Tracked changes. Biological evaluation of medical devices Tests for skin sensitization
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Standard number:
BS EN ISO 10993-10:2023 - TC
Pages:
172
Released:
2023-02-17
ISBN:
978 0 539 25922 3
Status:
Tracked Changes
DESCRIPTION
BS EN ISO 10993-10:2023 - TC
This standard BS EN ISO 10993-10:2023 - TC Tracked changes. Biological evaluation of medical devices is classified in these ICS categories:
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 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.
