DIN EN ISO 15882:2008-12

This document provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes. This document applies to chemical indicators that show exposure to sterilization processes by means of physical and/or chemical changes of substnaces, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. These chemical indicators are not dependet for their action on the presence or absence of a living organism. This document does not consider indicators for use in those processes that rely on physical removal of microorganisms, e. g., filtration. This document is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).