AAMI ANSI/AAMI/ISO 10993-10:2010/(R)2014

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

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AAMI ANSI/AAMI/ISO 10993-10:2010/(R)2014

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

PUBLISH DATE 2010
AAMI ANSI/AAMI/ISO 10993-10:2010/(R)2014
Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. Includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
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