• AAMI ISO 11140-5 : 2007

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2021

    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 11140-5:2007
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Indicator system
      5.1 Format
      5.2 Performance
    6 Indicator
      6.1 Format
      6.2 Performance
    7 Packaging and labeling
    8 Quality assurance
    9 Sampling conditioning
    Annex A (normative) Determination of the degree of
            contrast between the color of the substrate
            and the indicator agent
    Annex B (normative) Method of determining uniform
            color change on exposure to saturated steam
    Annex C (normative) Method for determining indicator
            color change on exposure to dry heat
    Annex D (normative) Method for determining transfer of
            indicator agent to standard test pack
    Annex E (normative) Standard test pack
    Annex F (normative) Method of determining non-uniform
            color change on exposure to a standard fault
            condition
    Annex G (normative) Steam exposure apparatus
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

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

    Committee WG 06
    Development Note Supersedes AAMI ST66. (06/2007)
    Document Type Standard
    Product Note Reconfirmed 2007
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    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
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    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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