ISO 18472:2018
Sterilization of health care products — Biological and chemical indicators — Test equipment
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.
ISO 11138‑2:2017, ISO 11138‑3:2017, ISO 11138‑4:2017 and ISO 11140‑1:2014 require the use of 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 11140‑4:2007, and ISO 11140‑5:2007.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements for resistometers
4.1 Intended use
4.2 Test methods
4.3 Air leakage test
4.4 Steam resistometer performance requirements
4.4.1 Measurement accuracy
4.4.2 Data
4.4.3 Process control
4.4.4 General steam resistometer requirements
4.4.5 Air leakage test
4.4.6 Operation of steam resistometer
4.5 Ethylene oxide gas resistometer performance requirements
4.5.1 Measurement accuracy
4.5.2 Data
4.5.3 Process control
4.5.4 General ethylene oxide gas resistometer requirements
4.5.5 Air leakage test
4.5.6 Operation of ethylene oxide gas resistometer
4.6 Dry heat (heated air) resistometer performance requirements
4.6.1 Measurement accuracy
4.6.2 Data
4.6.3 Process control
4.6.4 General dry heat (heated air) resistometer requirements
4.6.5 Operation of dry heat (heated air) resistometer
4.7 Vaporized hydrogen peroxide resistometer performance requirements
4.7.1 Measurement accuracy
4.7.2 Recording interval
4.7.3 Process control
4.7.4 General vaporized hydrogen peroxide resistometer requirements
4.7.5 Air leakage test
4.7.6 Operation of vaporized hydrogen peroxide resistometer
5 Calibration
Annex A (informative) Additional performance characterization — Steam
Annex B (informative) Additional performance characterization — Ethylene oxide gas
Annex C (informative) Additional performance characterization — Dry heat
Annex D (informative) Resistometer documentation and derivations
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements for resistometers
4.1 Intended use
4.2 Test methods
4.3 Air leakage test
4.4 Steam resistometer performance requirements
4.4.1 Measurement accuracy
4.4.2 Data
4.4.3 Process control
4.4.4 General steam resistometer requirements
4.4.5 Air leakage test
4.4.6 Operation of steam resistometer
4.5 Ethylene oxide gas resistometer performance requirements
4.5.1 Measurement accuracy
4.5.2 Data
4.5.3 Process control
4.5.4 General ethylene oxide gas resistometer requirements
4.5.5 Air leakage test
4.5.6 Operation of ethylene oxide gas resistometer
4.6 Dry heat (heated air) resistometer performance requirements
4.6.1 Measurement accuracy
4.6.2 Data
4.6.3 Process control
4.6.4 General dry heat (heated air) resistometer requirements
4.6.5 Operation of dry heat (heated air) resistometer
4.7 Vaporized hydrogen peroxide resistometer performance requirements
4.7.1 Measurement accuracy
4.7.2 Recording interval
4.7.3 Process control
4.7.4 General vaporized hydrogen peroxide resistometer requirements
4.7.5 Air leakage test
4.7.6 Operation of vaporized hydrogen peroxide resistometer
5 Calibration
Annex A (informative) Additional performance characterization — Steam
Annex B (informative) Additional performance characterization — Ethylene oxide gas
Annex C (informative) Additional performance characterization — Dry heat
Annex D (informative) Resistometer documentation and derivations
Bibliography