THE INFLUENCE OF IONISING RADIATION (BETA/GAMMA) ON VARIOUS POLYMERS BASED ON THE RESULT OF THE CYTOTOXICITY TEST

摘要

Ever more frequently, manufacturers of medical devices are being questioned by official authorities regarding the possibility of radiolysis products arising when medical devices and outer packaging of Pharmaceuticals are sterilised by means of radiation. The determination of the growth inhibition via the cytotoxicity test in Dubbecco's modified Eagle's medium (DMEM) with 10% fetal calf serum (FKS) makes possible a reliable prediction as to whether questionable radiolysis products arise. The result of the most diversified plastic product materials usually used as raw material for the production of medical devices, will be presented. Furthermore, the influence of the sterilization method (Beta and Gamma [Co-60] rays) and the results of the various irradiation doses will be investigated. These results enable the manufacturers to select suitable raw materials for their medical devices prior to their production.