ISO 11138-2:2006 医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌过程用生物指示物

标准编号：ISO 11138-2:2006

中文名称：医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌过程用生物指示物

英文名称：Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

发布日期：2006-07

标准范围

ISO 11138-2:2006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具体要求，用于评估使用环氧乙烷气体作为灭菌剂的灭菌器和灭菌过程的性能，无论是作为纯环氧乙烷气体还是该气体与稀释气体的混合物，灭菌温度在29°C至65°C范围内。

ISO 11138-2:2006 provides specific 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.

标准预览图