AAMI 10993-12

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Biological evaluation of medical devices – Part 12: Sample preparation andreference materials
2012 Edition, 2012

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  • Revision:2012 Edition, 2012
  • Published Date:January 2012
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:37
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 specifies requirements and gives guidanceon the procedures to be followed in the preparation of samples andthe selection of reference materials for medical device testing inbiological systems in accordance with one or more parts of ISO10993. Specifically, this part of ISO 10993 addresses thefollowing:

    — test sample selection;

    — selection of representative portions from a device;

    — test sample preparation;

    — experimental controls;

    — selection of, and requirements, for reference materials;

    — preparation of extracts.

    This part of ISO 10993 is not applicable to live cells, but canbe relevant to the material or device components of combinationproducts containing live cells.