ISO 11138-2:2017规定了测试生物体，悬浮液，接种载体，生物指示剂和测试方法的要求，用于评估灭菌剂的性能和使用环氧乙烷气体作为灭菌剂的灭菌方法，纯化的环氧乙烷气体或该气体与稀释气体的混合物，灭菌温度范围为29°C至65°C。 注1:环氧乙烷灭菌过程的验证和控制要求由ISO 11135和ISO 14937提供。 注2:国家或地区法规可以为工作场所安全提供要求

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.