DIN EN ISO 10993-13:2009-08

The document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished medical devices ready for clinical use. It describes two test methods to generate degradtion products, an accelerated degradataion 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. It considers only those degradation products generated by a chemical alteration of the finished polymeric device.