The invention provides an ozone sterilization device and its sterilization method. The device comprises an ozone generation module a sterilization housing connected to the ozone generation module and a temperature control unit and a pressure management unit connected to the sterilization housing, wherein the sterilization housing has a confined space for accommodating a preserved object encapsulated by a medical grade dialysis container. The sterilization method comprises the steps of: first, evacuating air out of the confined space then pouring ozone gas into the confined space for filling up the confined space and the medical grade dialysis container to perform sterilization for a period of time and removing the ozone gas. The present invention makes use of ozone gas to perform sterilization, which can avoid the residual toxicity problem of other sterilizing gas. Furthermore, in conjunction with the use of the medical grade dialysis container, the post-sterilization preserved objects are maintained in an aseptic container to prevent the problems of bacteria growth and intrusion.一種臭氧式滅菌裝置及其滅菌方法,該裝置包含有一臭氧產生模組、一與該臭氧產生模組連接的滅菌殼體,以及與該滅菌殼體連接的一溫度管理單元和一壓力管理單元,其中滅菌殼體具有一密閉空間以容置一被包覆於一醫療級透析容器中的保存物。而該滅菌方法則是先對該密閉空間進行抽氣,再灌入臭氧氣體於該密閉空間內,並充滿該密閉空間及醫療級透析容器中後維持一滅菌時間後,移除臭氧氣體。本發明利用臭氧氣體滅菌的方式避免其他滅菌氣體的毒性殘留問題,並配合醫療級透析容器的使用,使滅菌後的保存物維持在無菌的容器中,避免細菌的滋生及侵入問題。10...臭氧產生模組11...氧氣製造單元12...臭氧製造單元13...排氣閥131...通管14...臭氧儲存單元20...滅菌殼體30...溫度管理單元40...壓力管理單元60...醫療級透析容器