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
This part of ISO 11138 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.NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.NOTE 2 National or regional regulations could provide requirements for work place safety.
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