Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
保健产品的灭菌 - 生物指标 - 第3部分:湿热灭菌过程的生物指标
发布日期:
2017-03-03
ISO 11138-3:2017规定了用于评估使用湿热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 17665系列规定了湿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。
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.