Abstract

This Uganda Standard 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 alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behaviour in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This standard was PUBLISHED on 2011-12-20.