Bruck S D, Mueller E P
Biomedical Materials and Medical Devices Consulting Group, Stephen D. Bruck Associates, Inc., Rockville, Maryland 20851.
J Biomed Mater Res. 1988 Aug;22(A2 Suppl):133-44. doi: 10.1002/jbm.820221306.
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.
由与组织和/或血液接触的聚合生物材料制成的医疗器械和植入物的高能辐射灭菌，可能会对其长期机械性能和/或生物学性能（组织和/或血液相容性）产生不利影响。由于许多聚合植入物可能含有痕量的催化剂和/或其他添加剂，因此必须考虑高能辐射对这些添加剂的影响，以及在高能辐射影响下与聚合物链可能产生的协同效应。指出聚合植入物是用于短期（急性）还是长期（慢性）应用至关重要。短期内其物理化学、机械和生物学性能的相对小变化可能是可以容忍的，而类似的变化在长期应用中可能导致灾难性故障。因此，对于将通过高能辐射灭菌的聚合植入物，应仔细评估可能由辐射引起的长期性能变化。
