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ANSI/AAMI/ISO 10993-15:2019

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

Specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.

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Association for the Advancement of Medical Instrumentation [AAMI]


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