DANSK DS/EN ISO 10993-13 PDF

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying 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 degradation test as a screening method and a real-time degradation test in a simulated environment. 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 document considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. NOTE 1 Degradation products covered by this standard are formed primarily by chemical bond scission due to hydrolytic and/or oxidative processes in an aqueous environment such as the human body. It is recognized, however, that additional biological factors, such as enzymes, other proteins and cellular activity, can alter the rate and nature of degradation. NOTE 2 An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see ANNEX B). The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-17 and ISO 10993-16. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.