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ISO 10993-10:2021

Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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ISO 10993-10:2021

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

PUBLISH DATE 2026
ISO 10993-10:2021

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.

SDO ISO: International Organization for Standardization
Document Number ISO 10993
Publication Date April 1, 2026
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Publish Date Document Id Type View
April 1, 2026 ISO 10993-10:2021 Revision