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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

Summary

This standard 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. This second edition cancels and replaces the first edition (ISO 10993 15:2000), which has been technically revised. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2019
Page Count 0
Themes Biological Evaluation
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