This European Standard specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilization process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They can be designed to react to one or more of the critical process variables but can be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable.
Process indicators can be printed directly on packaging material or presented as self adhesive labels, packaging tapes, tags, etc.
Processes indicators have a defined end-point reaction.
BS EN 867-2:1997 history
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)