AAMI 10993-14

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Biological evaluation of medical devices — Part 14: Identification andquantification of degradation products from ceramics
1st Edition, 2001
Includes all amendments and changes through Reaffirmation Notice , 2011

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  • Revision:1st Edition, 2001
  • Published Date:January 2011
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:21
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 specifies two methods of obtainingsolutions of degradation products from ceramics (including glasses)for the purposes of quantification. It also gives guidance on theanalysis of these solutions in order to identify the degradationproducts. Because of the generalized nature of this part of ISO10993, product specific standards, when available, that address thedegradation product formation under more relevant conditions ofuse, should be considered first.

    This part of ISO 10993 considers only those degradation productsgenerated by a chemical dissociation of ceramics during in vitrotesting. No degradation induced by mechanical stress or externalenergy is covered. It is noted that while ISO 6872 and ISO 9693 arechemical degradation tests, they do not address the analysis ofdegradation products.

    Because of the range of ceramics used in medical devices and thedifferent requirements for accuracy and precision of the results,no specific analytical techniques are identified. Further, thispart of ISO 10993 provides no specific requirements for acceptablelevels of degradation products.

    Although these materials are intended for biomedicalapplications, the biological activity of these degradation productsis not addressed in this part of ISO 10993.