ISO/TC 194/WG 2 - Degradation aspects related to biological testing

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.

ISO 10993‑13:2010 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. ISO 10993‑13:2010 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 that 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. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993‑13:2010 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.

ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.