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ISO 10993-10:2021

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

General information

Valid from 16.11.2021
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.11.2021
Main
27.07.2010
Main
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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