ISO 10993-10:2021

ISO 10993-10:2021

November 2021
International standard Current

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.

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International ISO standards

Publication date

November 2021

Number of pages

51 p.

Reference

ISO 10993-10:2021

ICS Codes

11.100.20   Biological evaluation of medical devices

Print number

1
Sumary
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.

Replaced standards (1)
ISO 10993-10:2010
August 2010
International standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization

<p>ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.</p> <p>ISO 10993-10:2010 includes:</p> <ul> <li>pretest considerations for irritation, including <i>in silico</i> and <i>in vitro</i> methods for dermal exposure;</li> <li>details of <i>in vivo</i> (irritation and sensitization) test procedures;</li> <li>key factors for the interpretation of the results.</li> </ul> <p>Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.</p>

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