Standard: AAMI 10993-10

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION

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Scope:

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

This part of ISO 10993 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;

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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 10993-10
Publish Date: 2010-01-01
Page Count: 88
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 10993-10 Change Type: STCH Update Date: 2010-01-01 Revision: 10 Status: ACTV

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