Study On Tissue Compatibility And Teratogenicity Of The Radiation Sterilized Disposable Burette Transfusion Apparatus

Objective To study tissue compatibility and teratogenicity of theradiation sterilized disposable burette transfusion apparatus, in order toprovide envidence for the safety of radiation sterilized medical devices.Methods The initial bacteria burden of the burette transfusion apparatuswas examed according to the ISO11737standard, the cytotoxicitytest,sensitization test,dermal irritation test were performed to evaluate the tissuecompatibility of the sample products,and the teratogenicity was investigated withchromosomal aberration assay and micronucleus test as well.Results The study determined the verified sterilizing dosage at thelevel of9.4kGy, The radiation sterilized sample products had no cytotoxicity,no sensitization,no intracutaneous irritation,no genotoxicity in chromosomeaberration test, and will not increase the micronucleus rate of PCE.Conclusion Disposable burette transfusion apparatus showed good tissuecompatibility and no teratogenicity after radiation sterilization.Radiationsterilization is a biologically safe method for sterilization of medical devices.