标准摘要
[中文适用范围]： 包括但不限于医疗器械、制药设备和相关灭菌设备的制造商、使用者和监管机构。标准内容详细描述了用于验证灭菌过程有效性的实验方法和操作流程，为相关行业提供了统一的技术规范和操作指南。 ***此介绍可能不准确，请注意参考原文。 [外文原描述]： ISO 11138-4:2017 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.
英文名称Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes