ISO 11138-5:2017 保健产品的消毒 生物指示剂 第5部分： 低温蒸气及甲醛消毒用生物指示剂

标准编号：ISO 11138-5:2017

中文名称：保健产品的消毒 生物指示剂 第5部分： 低温蒸气及甲醛消毒用生物指示剂

英文名称：Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

发布日期：2017-03

标准范围

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 14937规定了低温蒸汽和甲醛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 11138-5:2017 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.

标准预览图