• AAMI ISO 11140-4 : 2007 : R2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - 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    Superseded date:  09-05-2020

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    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

    Abstract - (Show below) - (Hide below)

    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).

    General Product Information - (Show below) - (Hide below)

    Committee WG 06
    Document Type Standard
    Product Note Reconfirmed 2012
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    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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