DANSK DSF/FPREN ISO 18472 PDF

This International Standard specifies the requirements for test equipment to be used to: – test biological Indicators for steam, ethylene oxide and dry heat processes for conformity to the requirements given in ISO 11138; – test chemical indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. This International Standard 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. ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this International Standard, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 and ISO 11140. NOTE – Resistometers for low temperature steam and formaldehyde indicators are not included in this International Standard. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138-5. Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140-3 and ISO 11140-4.