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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.

Medical implant materials that come in contact with tissues, body fluids (including blood) constitute an area in medical devices where reliability and clinical performance limitations are vital. Polymeric implant materials differ in important aspects from metals and alloys, and ceramics (including glasses and carbons) with respect to their atomic and molecular structures and morphology. It is suggested that four categories of 'standards' be developed: (1) certified primary reference materials to be used for calibration purposes, (2) reference materials to be used for the comparative evaluation of physico-chemical and biological properties, (3) 'fabrication-grade' reference materials for intercomparative evaluation of processing conditions, and (4) reference implants aimed at the intercomparative evaluation of possible synergistic effects of additives, processing aids, and fabrication processes on in vivo service life, including biological and mechanical performance.