CAN/CSA-ISO 10993.9-98

The international community has decided to make this standard available only in the English language version. It has been adopted as a National Standard of Canada on this basis. This National Standard of Canada is equivalent to International Standard ISo 10993-9:1994. 1 Scope This Technical Report aims to facilitate the design of test procedures which are used to evaluate the biological responses to degradation products released from medical devices. Following brief descriptions of each major class of material used for medical devices, this Technical Report focuses on the likely mechanisms of degradation of these materials when they are used in a biological service environment. Accelerated time and real-time degradation testing environments for devices and materials are suggested along with characterization techniques for the degradation products. Finally, an approach for identifying and quantifying degradation products obtained from explanted devices and tissues is proposed.