Abstract

This Uganda Standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This standard describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer.