ISO 11138-4:2017规定了在120°C至180°C的灭菌温度范围内，用于评估使用干热作为灭菌剂的灭菌过程性能的试验生物体、悬浮液、接种载体、生物指示剂和试验方法的要求。 注1:ISO 20857规定了干热灭菌过程的验证和控制要求。 注2:国家或地区法规可提供工作场所安全要求。

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.