医用脉动真空高压蒸汽灭菌设备的验证

Temperature Measurement for Validation of Clinical Moist Sterilizers

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。

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.CONCLUSIONS 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.