AS ISO 10993.15-2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2017
English
01-01-2003
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.
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