Feasibility Discussion of Ethylene Oxide Sterilization Process for Collagen-Coated Artificial Blood Vessels

To investigate the impact of ethylene oxide sterilization on the properties of collagen-coated artificial blood vessels, the microscopic morphology, infrared spectroscopy, and collagen identification of collagen-coated artificial blood vessels before and after ethylene oxide sterilization were characterized using scanning electron microscopy-energy dispersive spectrometer （SEM-EDS）, Fourier transform infrared spectroscopy （FTIR）, and high performance liquid chromatography （HPLC）. Gas chromatography （GC） was employed to determine the residual ethylene oxide in the collagen-coated artificial blood vessels after ethylene oxide sterilization. Additionally, the cytotoxicity of the collagen-coated artificial blood vessels after ethylene oxide sterilization was evaluated using the tetrazolium （MTT） assay. As shown by the results, the collagen-coated artificial blood vessels after ethylene oxide sterilization underwent no structural changes, maintaining its intrinsic molecular structure and effective content. The residual amount of ethylene oxide in the collagen-coated artificial blood vessels after ethylene oxide sterilization was 1.85 μg·g⁻¹ （P＜0.005）, complying with safety standards. Additionally, the cell viability rate was 84.01%, meeting essential requirements for clinical application.