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目的研究低温蒸汽甲醛灭菌柜灭菌性能和安全性能。方法采用载体定性灭菌试验方法,观察不同类型载体上生物指示物的灭菌效果。结果在灭菌柜满载条件下,通入甲醛蒸汽混合气体维持灭菌温度80℃,灭菌腔内甲醛浓度为100 mg/L,维持灭菌时间为12.5 min,对管型PCD内不锈钢、特氟龙和PVC等3种载体上嗜热脂肪杆菌芽孢达到灭菌效果;对模拟医疗器械染菌载体上的嗜热脂肪杆菌芽孢完全杀灭。在灭菌条件下,灭菌柜周围空气中和模拟指示物上残留甲醛均达到相关标准规定的允许值要求。结论本研究国产医用低温蒸汽甲醛灭菌柜具有良好的灭菌性能和使用安全性。
Objective To study the sterilization performance and safety performance of low temperature steam formaldehyde sterilization cabinet. Methods The method of qualitative sterilization was used to observe the sterilization effect of biological indicators on different types of carriers. Results Under the condition of full load of sterilizer, the mixture of formaldehyde and steam was introduced to maintain the sterilization temperature of 80 ℃, the concentration of formaldehyde in the sterilization chamber to 100 mg / L and the sterilization time to 12.5 min, Fluoride and PVC on three kinds of carriers such as Bacillus stearothermophilus bactericidal effect; simulation of medical device bacteria carrier Bacillus stearothermophilus complete kill. Under the condition of sterilization, the residual formaldehyde in the air around the sterilizer and on the simulated indicator reached the allowable value required by relevant standards. Conclusion This study made domestic medical low-temperature steam formaldehyde sterilization cabinet has good sterilization performance and safety.