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
This document 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.
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