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ANSI/AAMI/ISO 10993-15:2000 (R2011)

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding materials samples finished as ready for clinical use.

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Association for the Advancement of Medical Instrumentation [aami]

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