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AAMI ISO 11140-4 : 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

08-31-2021

Language(s)

English

Published date

01-01-2012

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11140-4:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labeling
8 Quality assurance
Annex A (normative) Determination of indicator strength
        during and after steam sterilization
Annex B (normative) Standard test cycles
Annex C (normative) Estimation of visual difference between
        color of the substrate and of the changed or
        unchanged indicator system by determination of
        relative reflectance density
Annex D (normative) Determination of uniform color change
        on exposure to saturated steam
Annex E (normative) Determination of equivalence of the
        alternative indicator to the Bowie and Dick test
Annex F (normative) Determination of reproducibility of fail
        conditions created in a standard test pack by air
        injection, air leak, and retained air systems
Annex G (normative) Determination of indicator color change
        on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated aging of test samples
Annex J (normative) Steam exposure apparatus and steam
        for test purposes
Annex K (normative) Standard test pack
Annex L (normative) Air injection system
Bibliography

Specifies performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (e.g., instruments and porous loads).

Committee
WG 06
DocumentType
Standard
Pages
48
ProductNote
Reconfirmed 2007
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 11140-4:2007 Identical

ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
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 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015 Quality management systems — Requirements
ISO/CIE 10526:1999 CIE standard illuminants for colorimetry
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
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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