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EN ISO 18472:2006

Superseded

Superseded

View Superseded by

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

Published date

06-01-2006

Superseded date

09-19-2018

Superseded by

EN ISO 18472:2018

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Summarise this standard

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements for resistometers
  4.1 Intended use
  4.2 Measurement and control capabilities
  4.3 Test methods
  4.4 Leak test
  4.5 Steam resistometer performance requirements
  4.6 Ethylene oxide resistometer performance requirements
  4.7 Dry heat (heated air) resistometer performance
      requirements
  4.8 Vaporized hydrogen peroxide process resistometer
      performance requirements
5 Recording systems
  5.1 Measurement systems
  5.2 Calibration
6 Documentation
  6.1 General
  6.2 Minimum information
Annex A (informative) Additional performance characterization
        - Steam
Annex B (informative) Additional performance characterization
        - Ethylene oxide
Annex C (informative) Additional performance characterization
        - Dry heat
Annex D (informative) Resistometer documentation and derivations
Bibliography

ISO 18472:2006 specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. ISO 18472:2006 also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.

Committee
CEN/TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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