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AAMI 10993-15

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Biological evaluation of medical devices — Part 15: Identification andquantification of degradation products from metals and alloys
2000
Includes all amendments and changes through Reaffirmation Notice , 2011

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Description

  • Revision:2000
  • Published Date:January 2011
  • 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 guidance on general requirementsfor the design of tests for identifying and quantifying degradationproducts from finished metallic medical devices or correspondingmaterial samples finished as ready for clinical use. It isapplicable only to those degradation products generated by chemicalalteration of the finished metallic device in an in vitroaccelerated degradation test. Because of the accelerated nature ofthese tests, the test results may not reflect the implant ormaterial behavior in the body. The described chemical methodologiesare a means to generate degradation products for furtherassessments.

    This part of ISO 10993 is not applicable to degradation productsinduced by applied mechanical stress.

    NOTE—Mechanically induced degradation, such as wear, may becovered in the appropriate product-specific standard. Whereproduct-group standards provide applicable product-specificmethodologies for the identification and quantification ofdegradation products, those standards should be considered.

    Because of the wide range of metallic materials used in medicaldevices, no specific analytical techniques are identified forquantifying the degradation products. The identification of traceelements (less-than 10 –6) contained in the specificmetal or alloy is not addressed in this part of ISO 10993, nor arespecific requirements for acceptable levels of degradation productsprovided in this part of ISO 10993.

    This part of ISO 10993 does not address the biological activityof the degradation products; see instead the applicable clauses ofISO 10993-1 and ISO 10993-17.