BS EN ISO 11138-2:2017规定了测试生物体、悬浮液、接种载体和生物制剂的要求 用于评估灭菌器和灭菌设备性能的指标和试验方法 使用环氧乙烷气体作为灭菌剂的工艺，可以是纯环氧乙烷气体，也可以是 该气体与稀释气体的混合物，灭菌温度在29°C至65°C之间。注1环氧乙烷灭菌过程的验证和控制要求由 ISO 11135和ISO 14937。注2:国家或地区法规可提供工作场所安全要求。交叉引用:ISO 11138-1:2017ISO 18472ISO 11135ISO 14161ISO 14937购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.NOTE 2 National or regional regulations can provide requirements for work place safety.Cross References:ISO 11138-1:2017ISO 18472ISO 11135ISO 14161ISO 14937All current amendments available at time of purchase are included with the purchase of this document.