A guide is provided 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 that are intended to polymerize in situ, the set or cured polymer is used for testing. Data generated is used in the biological evaluation of the polymer. This standard considers only those degradation products generated by a chemical alteration of the finished polymeric device.

ISO 10993-13:1998 - Identical