ISO 18472:2018 PDF

Scope: This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; — test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014. This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure. resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series. Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138-5:2017. Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140-3:2007,

ISO 18472:2018 Referenced Document

ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements

2018 ISO 18472:2018 Sterilization of health care products - Biological and chemical indicators - Test equipment
2006 ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment