标准摘要
[中文适用范围]： 1.1 本国际标准为灭菌过程的过程定义、验证和常规监测以及总体控制中使用的化学指示剂的选择、使用和结果解释提供了指导。 本国际标准适用于通过物质的物理和/或化学变化显示灭菌过程暴露情况的指示器，并用于监测灭菌过程所需的一个或多个变量。 这些化学指示剂的作用并不依赖于生物体的存在或不存在。1.2 本国际标准不考虑用于依赖物理去除微生物的过程（例如过滤）的指标。1.3 本国际标准不适用于组合过程中使用的指示器，例如清洗消毒器或 CIP（就地清洁）和 SIP（就地灭菌）。 [外文原描述]： ISO 15882:2008 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.
英文名称Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results