【摘要】 目的:研究不同一次性敷料型B-D测试包产品和管腔状检测产品对压力蒸汽灭菌器抽真空不彻底以及空气泄漏检测的敏感性对比和理论分析。方法:严格按照ISO11140-4/5:2006.12.14的测试方法,在低大气压、跨大气压以及高大气压循环条件下通过抽真空不彻底、空气泄漏以及空气注入等方法对以上不同产品进行全面、系统的研究对比。结果:一次性敷料型B-D测试包产品对抽真空不彻底和空气泄漏具有较好的敏感性以及较稳定的变色指示。但由于不同一次性敷料型B-D测试包产品的结构不同,其对压力蒸汽灭菌器冷空气残留的检测敏感性也存在差异。管腔状检测产品对抽真空不彻底过于敏感,可能会造成假阳性的测试结果;对空气泄漏或注入的监测,其变色性能不稳定,可能会有假阴性的测试结果。更多还原

【Abstract】 Objective: To compare the sensitivity of different B-D test pack products and helix test products to air removal efficiency of the steam sterilizer.Methods: According to ISO11140-4/5 standards,the adequate vacuum,inadequate vacuum,air leakage and air injection test methods in sub-atmospheric pulsing,trans-atmospheric pulsing and super-atmospheric pulsing cycles were used to evaluate above products.Results: The imported B-D test pack has good and stable sensitivity to both the air residual and air leakage of the steam sterilizer;the local B-D pack is too easy to change color,and has bad sensitivity to air residual and air leakage,as a result,it is easy to show the unreal pass cycle.Helix product is too sensitive to the air residual failure cycle,which will lead to the unreal failure cycle;and the test result is unstable which will result in the unreal pass cycle.更多还原