Radiation sterilization of polymeric implant materials.
High-energy irradiation sterilization of medical devices and implants composed of polymeric biomaterials that are in contact with tissue and/or blood, may adversely affect their long-term mechanical and/or biological performance (tissue and/or blood compatibility). Since many polymeric implants may contain trace quantities of catalysts and/or other additives, the effect of high-energy radiation on these additives, and possible synergistic effects with the polymer chains under the influence of high-energy radiation, must be considered. It is essential to indicate whether polymeric implants are used in short-term (acute) or long-term (chronic) applications. Relatively small changes in their physicochemical, mechanical, and biological properties may be tolerable in the short term, whereas similar changes may lead to catastrophic failures in long-term applications. Therefore, polymeric implants which are to be sterilized by high-energy irradiation should be carefully evaluated for long-term property changes which may be induced by the radiation.
Bruck
S D
SD
Biomedical Materials and Medical Devices Consulting Group, Stephen D. Bruck Associates, Inc., Rockville, Maryland 20851.
Mueller
E P
EP
D001672:Biocompatible Materials / Q000528:radiation effects; D011108:Polymers; D019736:Prostheses and Implants; D011839:Radiation, Ionizing; D013242:Sterilization / Q000379:methods*
D001672:Biocompatible Materials; D011108:Polymers