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Norm

ISO 10993-10:2021

Issue date: 2021 11 16

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

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. T...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 48 Pages
Language:
English

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
2021 11 16
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Norm
ISO 10993-10:2010
2010 07 27
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Norm
ISO 10993-10:2002/Amd 1:2006
2006 07 06
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ISO 10993-10:2002
2002 09 26
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ISO 10993-10:1995
1995 03 09
Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization
Norm
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