DIN EN ISO 10993-15:2001-11

The document provides 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 applicable only to those degradation products generated by chemical alternation of the finished metallic device in a vito accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behaviour in the bodey. The described chemical methodologies are a means generated degradation products for further assessments.