医用脉动真空高压蒸汽灭菌设备的验证.pdfVIP

中华医院感染学杂志2008年第 18卷第 4期 · 论 著 · 医用脉动真空高压蒸汽灭菌设备的验证 张 青 ，张金涛 ，高 宏 ，段宇宁 ，邱 萍。 (1．北京协和医院供应室，北京 100730；2 中国计蘑科学研究院热工所，北京 100013) 摘要：目的 验证医用脉动真空高压蒸汽灭菌设备的性能。方法 采用无线温度记录仪，根据先进的灭菌设备 验证标准，对使用的高压蒸汽灭菌过程进行温度检测，同时也进行了生物检测。结果 测量给出了被测灭菌设备 舱室和灭菌产品装载内的温度时间关系。结论 测量结果直观地指示灭菌设备运行情况和装载内的温度时间关 系，有利于保障医疗灭菌质量；生物检测结果与对应温度检测结论一致，显示为阴性。 关键词：灭菌；验证；灭菌装载 中图分类号：R187 ．5 文献标识码：A 文章编号：1005—4529(2008)04—0529一O3 Temperature Measurement for Validation of Clinical Moist Sterilizers ZHANG Qing ，ZHANG Jin-tao，GAO Hong，DUAN Yu—ning，QIU Ping (Peking Union Medical College Hospital，Beijing 100730，China) Abstract：OBJECTIVE To report the investigation on validating clinical moist sterilizer by applying wireless thermo—loggers in accordance with the advanced Euro and British standards．METHODS The validation had been implemented with microbiological tests and thermometric tests to measure the temperature distribution of the chamber of sterilizer，the temperature and time relation inside the tested package of small and challenge loads，the pressure of the chamber and the temperature beside the drainage．RESULTS The measurements presented the relation between temperature and time measurements of the spots inside the chamber of the tested sterilization loads．C0NCLUSl0NS The measurement results indicate directly the operation condition and the temperature-time relation inside sterilization loads．These measurements are helpful for controlling sterilization quality．The results of microbiological tests are negative，which are consistent with that of thermomeric tests． Key words：Sterilization；Validation Sterilization load 高压蒸汽灭菌是医用物品、器械灭菌的首选方 了分析。现报道如下。 法，高压蒸汽灭菌的方法和质量控制要求也有明确 1 测试条件 的规定[1 ]。如我国卫生部颁布的《消毒技术规范》 对灭菌过程的暴露温度与暴露时间、生物与化学检 选定1台洁定脉动真空高压蒸汽灭菌器作为