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AAMI 10993-13

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Biological evaluation of medical devices – Part 13: Identification andquantification of degradation products from polymeric medical devices
2010 Edition, 2010
Includes all amendments and changes through Reaffirmation Notice , 2014

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Description

  • 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:28
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 provides general requirements for thedesign of tests in a simulated environment for identifying andquantifying degradation products from finished polymeric medicaldevices ready for clinical use.

    This part of ISO 10993 describes two test methods to generatedegradation products, an accelerated degradation test as ascreening method and a real-time degradation test in a simulatedenvironment. For materials that are intended to polymerize in situ,the set or cured polymer is used for testing. The data generatedare used in the biological evaluation of the polymer. This part ofISO 10993 considers only non-resorbable polymers. Similar butappropriately modified procedures may be applicable for resorbablepolymers.

    This part of ISO 10993 considers only those degradation productsgenerated by a chemical alteration of the finished polymericdevice. It is not applicable to degradation of the device inducedduring its intended use by mechanical stress, wear orelectromagnetic radiation or biological factors such as enzymes,other proteins and cellular activity.

    NOTE An informative text discussing environmental stresscracking (ESC) of polymers is included as a potential aid to thedesign of degradation studies (see Annex B).

    The biological activity of the debris and soluble degradationproducts is not addressed in this part of ISO 10993, but should beevaluated according to the principles of ISO 10993-1, ISO 10993-16and ISO 10993-17.

    Because of the wide range of polymeric materials used in medicaldevices, no specific analytical techniques are identified or givenpreference. No specific requirements for acceptable levels ofdegradation products are provided in this part of ISO 10993.