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ANSI/AAMI/ISO 10993-13-2010 (R2014)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

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Association for the Advancement of Medical Instrumentation [aami]

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