标准编号：ISO 11138-3:2006
中文名称：保健产品的消毒 生物指示剂 第3部分：湿热消毒用生物指示剂.
英文名称：Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat 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 sterilization processes employing moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.NOTE 2 National or regional regulations may provide requirements for work place safety.
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