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ANSI/AAMI/ISO 10993-13-2010 (R2019)
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
This standard 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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]