ISO 10993-10:2021

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

Publication date: 16 nën 2021

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Current stage: 60.60 Effective date: 16 nën 2021

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht frëngjisht

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Statusi: Publikuar

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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.

ISO 10993-10:2021

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

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