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AAMI ISO 18472 : 2007

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Withdrawn date

04-17-2024

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 18472:2006
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

Defines the requirements for the 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.

Committee
WG 91
DevelopmentNote
Supersedes AAMI ST44 (02/2006)
DocumentType
Standard
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Withdrawn
Supersedes

Standards Relationship
ISO 18472:2006 Identical

ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES

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
ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde 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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