Specifies 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. This Standard is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in-vitro accelerated degradation test.
AS ISO 10993.15-2003
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Biological evaluation of medical devices – Identification and quantification of degradation products from metals and alloys
Standards Australia , 01/01/2003
Pages: 12
