压力蒸汽灭菌器(STATIM5000)灭菌性能研究

STUDY ON THE STERILIZATION PERFORMANCE OF STATIM5000 STEAM STERILIZER

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 performance of STATIM5000 steam sterilizer. Methods Through the methods of simulated field sterilization tests of medical devices and PCD and using the thermometric instruments, to study the sterilization performance and physical parameters of STATIM5000 steam sterilizer. Results All of the medical devices （dental hand pieces, cannula of endoscope and lacto - knob） were sterilized through ＂non package＂ cycle （ 134 ℃, 3.5 min） for five repeated tests. There was small difference between detected value and set value, the color of bio - indicator was not changed by ＂non package＂ cycle （ 134 ℃, 3.5 rain） and ＂package＂ cycle （ 134 ℃, 6 min）, and the color of PCD was not changed by ＂package＂ cycle （ 134 ℃ 6 min） but changed by ＂ non package＂ cycle （ 134 ℃, 3.5 min）. Conclusion It was shown that the sterilizer had stable physical parameters and good performance. In daily self- monito- ring, it was need to choose the correct way.