Sterilization of health care products. Biological indicators-Biological indicators for moist 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 11138-3:2017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
使用湿热作为杀菌剂。注1:湿热灭菌过程的验证和控制要求由
ISO 17665系列。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 17665-1购买本文件时可获得的所有现行修订版均包含在购买本文件中。
BS EN 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.Cross References:ISO 11138-1:2017ISO 18472ISO 14161ISO 17665-1All current amendments available at time of purchase are included with the purchase of this document.