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

ISO-10993-10 - 4TH EDITION - CURRENT
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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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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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ISO-10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Document Number

ISO 10993-10:2021

Revision Level

4TH EDITION

Status

Current

Publication Date

Nov. 1, 2021

Committee Number

ISO/TC 194