Influence of ionizing irradiation in air and nitrogen for sterilization of surgical grade polyethylene for implants

The influence of the atmosphere and the applied dose during ionizing radiation treatment on selected properties of ultra high molecular weight polyethylene (UHMWPE) have been investigated. A linear correlation between extinction coefficient and applied doses in air from 6 to 125 kGy was found, while oxidation was not linear with irradiation in nitrogen. Bacteria survival rate shows a necessary minimum dose of 15 kGy for assured sterility of the product. Post reaction of latent free radicals in UHMWPE created during irradiation, which react or recombine time- and environment dependent, has also been investigated after storage of UHMWPE-films in air and nitrogen at 210C and in water at body temperature 370C for up to nine months. Results show that the properties of UHMWPE after radiation-sterilization change depending on time, the absorbed dose, the atmosphere where irradiation took place and the environment of storage. UHMWPE, which mainly crosslinks during irradiation degrades by an oxidation process after sterilizing when stored in air and even more in water at body temperature. So irradiation and storage in nitrogen before implantation in the human body is beneficial. (author)