Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
保健品灭菌——化学指示剂——结果的选择、使用和解释指南
发布日期:
2008-08-21
ISO 15882:2008提供了选择、使用和解释灭菌过程定义、验证、常规监测和总体控制中使用的化学指示剂结果的指南。
ISO 15882:2008适用于通过物质的物理和/或化学变化显示暴露于灭菌过程的指示器,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取决于是否存在活生物体。
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.