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ISO 10993-10:2021

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.


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.

Content Provider
International Organization for Standardization [iso]

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Document History
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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.