标准摘要
[中文适用范围]： 本文档规定了用于评估采用低温蒸汽和甲醛作为灭菌剂的灭菌过程性能的试验微生物、悬浮液、接种载体、生物指示剂和试验方法的要求。 注1：低温蒸汽和甲醛灭菌过程的验证和控制要求由ISO 14937提供。 注2：工作场所安全要求可由国家或区域法规提供。 [外文原描述]： ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937. 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 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes