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I.S. EN ISO 18472:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

09-10-2018

Language(s)

English

Published date

01-01-2006

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Pages
40
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 10013:1995 Guidelines for developing quality manuals
ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

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£64.06
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