ISO 11140-1:2005 医疗保健产品的灭菌 化学指示剂 第1部分：一般要求

标准编号：ISO 11140-1:2005

中文名称：医疗保健产品的灭菌 化学指示剂 第1部分：一般要求

英文名称：Sterilization of health care products — Chemical indicators — Part 1: General requirements

发布日期：2005-07

标准范围

ISO 11140-1:2005规定了通过物质的物理和/或化学变化显示暴露于灭菌过程中的指示剂的一般要求和试验方法，并用于监测灭菌过程所需的一个或多个变量的实现情况。它们的行为不依赖于有无活生物体。ISO 11140-1:2005的要求和试验方法适用于ISO 11140后续部分中规定的所有指标，除非后续部分对该要求进行了修改或添加，在这种情况下，该特定部分的要求将适用。

ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

标准预览图