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ISO 10993-10:2021

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

Publication date:   Nov 16, 2021

General information

60.60 Standard published   Nov 16, 2021

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-10:2010

NOW

PUBLISHED
ISO 10993-10:2021
60.60 Standard published
Nov 16, 2021