AAMI 10993-2

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Biological evaluation of medical devices – Part 2: Animal welfarerequirements
6th Edition, 2006
Includes all amendments and changes through Reaffirmation Notice , 2014

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  • Revision:6th Edition, 2006
  • Published Date:January 2014
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:29
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 is aimed at those who commission, designand perform tests or evaluate data from animal tests undertaken toassess the biocompatibility of materials intended for use inmedical devices, or that of the medical devices themselves. Itspecifies the minimum requirements to be satisfied to ensure anddemonstrate that proper provision has been made for the welfare ofanimals used in animal tests to assess the biocompatibility ofmaterials used in medical devices.

    It also makes recommendations and offers guidance intended tofacilitate future further reductions in the overall number ofanimals used, refinement of test methods to reduce or eliminatepain or distress in animals, and the replacement of animal tests byother scientifically valid means not requiring animal tests.

    It applies to tests performed on living vertebrate animals,other than man, to establish the biocompatibility of materials ormedical devices.

    It does not apply to tests performed on invertebrate animals andother lower forms; nor (other than with respect to provisionsrelating to species, source, health status, and care andaccommodation) does it apply to testing performed on isolatedtissues and organs taken from vertebrate animals that have beeneuthanized.