Sterilization of health care products. Biological indicators-Biological indicators for dry heat sterilization processes
医疗保健产品的消毒 生物指标
发布日期:
2017-04-30
BS EN ISO 11138-4:2017规定了测试生物体、悬浮液、接种载体和生物制剂的要求
用于评估灭菌过程性能的指标和试验方法
使用干热作为杀菌剂,杀菌温度在120°C范围内?C到180?C.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。交叉引用:ISO 11138-1:2017ISO 18472ISO 14161ISO 20857购买本文件时提供的所有当前修订版均包含在购买本文件中。
BS EN 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.Cross References:ISO 11138-1:2017ISO 18472ISO 14161ISO 20857All current amendments available at time of purchase are included with the purchase of this document.