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Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

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Withdrawn date: 17-04-2024

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Published date: 01-01-2010

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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Committee	WG 91
Development Note	Supersedes AAMI ST44 (02/2006)
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Withdrawn
Supersedes	AAMI ISO 18472 : 2006 AAMI ST44 : 3ED 2002

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 18472:2006	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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