International Organization for Standardization (ISO)
Latest
ISO 15882:2008
Scope
1.1 This International Standard 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. This International Standard 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 of a sterilization process. These chemical
indicators are not dependent for their action on the presence or absence of a living organism.
1.2 This International Standard does not consider indicators for use in those processes that rely on
physical removal of microorganisms, e.g. filtration.
1.3 This International Standard 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).
ISO 15882:2008 history
2008ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
2003ISO 15882:2003 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results