Radiation sterilization of polymeric implant materials

✍ Scribed by Bruck, Stephen D. ;Mueller, Edward P.

• Publisher: John Wiley and Sons
• Year: 1988
• Tongue: English
• Weight: 672 KB
• Volume: 22
• Category: Article
• ISSN: 0021-9304
• DOI: 10.1002/jbm.820221306

✦ Synopsis

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. Rcla tively 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 s t e r ili z e d by highe n e r g y i r ra d i a ti o n should be carefully evaluated for long-term property changes which may be induced by the radi a t' Ion.