Study on tissue compatibility and genotoxicity of a radiation sterilized disposable burette transfusion apparatus

Abstract

The aim of the study was to evaluate the effect of radiation sterilization on biocompatibility of a disposable burette transfusion apparatus, in order to assess the safety of radiation sterilized medical devices. The initial bacteria burden of the burette transfusion apparatus was examed according to the ISO11737 standard, we combined cytotoxicity test, sensitization test and dermal irritation test to evaluate the tissue compatibility of the radiation sterilized samples, and the genotoxicity was investigated with chromosomal aberration test and micronucleus test. The study determined the verified sterilizing dosage at the level of 9.4kGy, results show the sample products had no cytotoxicity, no sensitization,no intracutaneous irritation, no genotoxicity in chromosome aberration test, and will not increase the micronucleus rate of PCE (p<0.05). Disposable burette transfusion apparatus showed good tissue compatibility and had no genotoxicity after radiation sterilization. Radiation sterilization is a biologically safe method for sterilization of medical devices.