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.