目的研究STATIM5000压力蒸汽灭菌器的灭菌性能。方法通过医疗器械模拟现场灭菌试验、灭菌验证装置(PCD)监测和温度验证仪监测等方法,对某STATIM5000压力蒸汽灭菌器灭菌性能及其他相关物理性能进行评价。结果将人工染菌的牙科手机、腔镜套管和超乳手柄裸露置于该灭菌器腔内,经134℃灭菌3.5 min,连续5次重复实验均达到灭菌要求。该灭菌器的物理参数设定值与温度验证仪测定值差距较小;裸露的生物指示物经“非包裹灭菌”循环(134℃、3.5 min)和“包裹灭菌”循环(134℃、6 min)后均不变色,但生物PCD经“非包裹灭菌”循环(134℃、3.5 min)后变色,经“包裹灭菌”循环(134℃、6 min)后不变色。结论该灭菌器物理参数稳定,灭菌性能较好;在其日常自我监测时,需选择正确的监测方式。 Objective To study the sterilization of STATIM5000 pressure steam sterilizer. Methods The sterilizing performance and other related physical properties of a STATIM5000 pressure steam sterilizer were evaluated by on-site sterilization experiments of medical devices, PCD and temperature monitor. Results The artificial hand-stained dental handpiece, endoscope cannula and phacoemulsion handle were exposed in the sterilizer chamber. After sterilized at 134 ℃ for 3.5 min, the experiments were repeated for 5 times to achieve the sterilization requirements. The difference between the set point of the physical parameters of the sterilizer and the value of the temperature verifier is small. The bare biological indicator is subjected to the “non-package sterilization” cycle (134 ° C, 3.5 min) and the “package sterilization” No discoloration occurred after cycling (134 ° C, 6 min), but the biochromatic PCD discolored after “non-package sterilization” circulation (134 ° C, 3.5 min) min) does not change color. Conclusion The sterilizer has stable physical parameters and good sterilization performance. In its daily self-monitoring, it is necessary to choose the correct monitoring method.