1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs).
1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in
subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.
Relevant test equipment is described in ISO 18472.
NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.
BS EN ISO 11140-1:2009 Referenced Document
ISO 11138 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator*， 2021-06-30 Update
ISO 11607 Packaging for terminally sterilized medical devices
ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*， 2018-07-31 Update
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
BS EN ISO 11140-1:2009 history
0000 BS EN ISO 11140-1:2014(2015)
2014BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
2009BS EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - General requirements
0000 BS EN ISO 11140-1:2005
1997BS EN 867-2:1997 Non-biological systems for use in sterilizers - Process indicators (Class A)