AAMI 10993-9

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Biological evaluation of medical devices – Part 9: Framework foridentification and quantification of potential degradation products
2009 Edition, 2009
Includes all amendments and changes through Reaffirmation Notice , 2014

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  • Revision:2009 Edition, 2009
  • Published Date:January 2014
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:22
  • ANSI Approved:Yes
  • DoD Adopted:No
  •  This part of ISO 10993 provides general principles for thesystematic evaluation of the potential and observed biodegradationof medical devices and for the design and performance ofbiodegradation studies. Information obtained from these studies canbe used in the biological evaluation described in the ISO 10993series. This part of ISO 10993 considers both non-resorbable andresorbable materials.

    This part of ISO 10993 is not applicable to:

    a) evaluation of degradation which occurs by purely mechanicalprocesses; methodologies for the production of this type ofdegradation product are described in specific product standards,where available;

    NOTE 1 Purely mechanical degradation causes mostly particulatematter. Although this is excluded from the scope of this part ofISO 10993, such degradation products can evoke a biologicalresponse and thus need to undergo biological evaluation asdescribed in other parts of ISO 10993.

    b) leachable components which are not degradation products;

    c) medical devices or components that do not contact thepatient's body directly or indirectly.

    NOTE 2 This part of ISO 10993 can be applied to the degradationof materials used in any kind of product that falls within thedefinition of "medical device" in ISO 10993-1, even if suchproducts are subject to different regulations from those applyingto medical devices, e.g. the scaffold in a tissue engineeredmedical product, or a carrier matrix to deliver drugs orbiologics.