标准编号：ISO 11138-4:2017
中文名称：医疗保健产品灭菌 生物指示物 第4部分：干热灭菌过程用生物指示物
英文名称：Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat 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 sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
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