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ISO 10993-10:2010

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

General information

90.92     Jan 12, 2018

ISO

ISO/TC 194

International Standard

11.100.20  

Scope

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.
ISO 10993-10:2010 includes:

pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.

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.

Life cycle

PREVIOUSLY

Revises
ISO 10993-10:2002

Revises
ISO 10993-10:2002/Amd 1:2006

NOW

PUBLISHED
ISO 10993-10:2010
90.92 Standard to be revised
Jan 12, 2018

REVISED BY

IN_DEVELOPMENT
ISO 10993-10

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