ISO 11138-5:2017规定了用于评估使用低温蒸汽和甲醛作为灭菌剂的灭菌方法的性能的测试生物体，悬浮液，接种载体，生物指示剂和测试方法的要求。 注1:ISO 14937提供了低温蒸汽和甲醛灭菌过程的验证和控制要求。 注2:工作场所安全要求可由国家或地区法规规定

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.