AAMI/ISO 15882:2008 (R2013)

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. 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.