What Data Should Be Provided At Least For Radiation Sterilization Verification Of Non-active Implant?

For verification of radiation sterilization verification of non­active implant, it is necessary to define the radiation source and radiation dose, provide the corresponding basis for such determination, as well as the initial average bioburden test report and dose verification test report, and provide the sterility test report of product after sterilization with minimum radiation dose determined based on the initial average bioburden. The radiation sterilization validation report should include the selection of the product and packaging materials, the determination of the product loading mode, and the product dose map, etc. It should be noted that the establishment of radiation dose for sterilization should not be based on biological indicators (generally bacillus pumilus spores), but should be based on microorganisms (e.g. bacillus stearothermophilus spores) that have stronger radiation resistance loaded in sterilization articles. If the product used for sterilization verification is not the product under application, it is necessary to provide the supporting data demonstrating its equivalence to the product under application in terms of raw materials, sterilization methods, sterilization doses, packaging materials, packaging processes, packaging methods, and other factors that affect resistance to bacteria.