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ONORM EN ISO 18472 : 2006

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
Withdrawn date

11-22-2018

Published date

01-12-2013

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

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.

DocumentType
Standard
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Withdrawn
SupersededBy

ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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