DR 03177 CP
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
10-26-2017
03-25-2003
Proposes guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test.
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