ISO 11138-2:2017 保健产品的消毒 生物指示剂 第2部分：乙烯氧化物杀菌的生物指示剂

标准编号：ISO 11138-2:2017

中文名称：保健产品的消毒 生物指示剂 第2部分：乙烯氧化物杀菌的生物指示剂

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

发布日期：2017-03

标准范围

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。注1:ISO 11135和ISO 14937规定了环氧乙烷灭菌过程的验证和控制要求。注2:国家或地区法规可提供工作场所安全要求。

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.

标准预览图