标准摘要
[中文适用范围]： 本文件规定了用于评估使用湿热作为灭菌剂的灭菌过程性能的测试生物体、悬浮液、接种载体、生物指示剂和测试方法的要求。 注 1：湿热灭菌过程的验证和控制要求由《注 2》规定。 国家或地区法规可以提供工作场所安全要求。 [外文原描述]： ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.
英文名称Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes