AAMI 10993-10

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Biological evaluation of medical devices – Part 10: Tests for irritationand skin sensitization
2010 Edition, 2010
Includes all amendments and changes through Reaffirmation Notice , 2014

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  • Revision:2010 Edition, 2010
  • Published Date:January 2014
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:88
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 describes the procedure for theassessment of medical devices and their constituent materials withregard to their potential to produce irritation and skinsensitization.

    This part of ISO 10993 includes:

    a) pretest considerations for irritation, including insilico and in vitro methods for dermal exposure;

    b) details of in vivo (irritation andsensitization) test procedures;

    c) key factors for the interpretation of the results.

    Instructions are given in Annex A for the preparation ofmaterials specifically in relation to the above tests. In Annex Bseveral special irritation tests are described for application ofmedical devices in areas other than skin.