ISO 11138-3:2006 保健产品的消毒 生物指示剂 第3部分：湿热消毒用生物指示剂.

标准编号：ISO 11138-3:2006

中文名称：保健产品的消毒 生物指示剂 第3部分：湿热消毒用生物指示剂.

英文名称：Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes

发布日期：2006-07

标准范围

ISO 11138-3:2006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具体要求。在ISO 11138-3:2006中，作为杀菌剂的湿热定义为干饱和蒸汽。虽然空气-蒸汽混合物可用于湿热灭菌过程，但ISO 11138本部分的方法和性能要求可能不适用于此类过程中使用的生物指示剂。

ISO 11138-3:2006 provides specific 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.Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

标准预览图