Biocompatibility and heat source evaluation on goose-head nail steel plates after radiation sterilization

摘要

The aim of this study was to detect biocompatibility and heat source of goose-head nail steel plates sterilization by radiation, so as to evaluate the safety of radiation as a method of sterilization of medical devices. We set radiation sterilization dose and combined sensitization test, intracutaneous irritation tests, chromosome aberration test, Ames test and a local reaction test after implantation to evaluate the biocompatibility of radiation sterilized goose-head nail steel plates, we also conducted a heat source test to check whether the sterilized samples still have any heat source. The results suggest that the test samples have no sensitization, no intracutaneous irritation, no genotoxicity in chromosome aberration test and Ames test, and no heat source was found. Radiation sterilization is a biologically safe method for sterilization of medical devices.