Document Center is acquired by Nimonik

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished polymeric medical devices ready for clinical use.This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradationtest 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.This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finishedpolymeric device. It is not applicable to degradation of the device induced during its intended use by mechanicalstress, wear or electromagnetic radiation.The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, butshould be evaluated according to the principles of ISO 10993-1 and ISO 14538.Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques areidentified or given preference. No specific requirements for acceptable levels of degradation products are providedin this part of ISO 10993.