EVS-EN ISO 10993-15:2009

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished metallic medical devices or corresponding material samples finishedas ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of thefinished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of thesetests, the test results may not reflect the implant or material behavior in the body. The described chemicalmethodologies are a means to generate degradation products for further assessments.This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.