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    I.S. EN ISO 11140-3:2009

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Indicator system format
    6 Performance requirements
    7 Packaging and labelling
    8 Quality assurance
    Annex A (normative) Determination of strength
            after steam sterilization
    Annex B (normative) Estimation of visual difference
            between colour of the substrate and the
            changed (or unchanged) indicator system by
            determination of relative reflectance density
    Annex C (normative) Determination of indicator colour
            change on exposure to dry saturated steam
    Annex D (normative) Determination of indicator colour
            change on exposure to dry heat
    Annex E (normative) Accelerated ageing of test samples
    Annex F (normative) Determination of transfer of indicator
            to standard test pack on processing
    Annex G (normative) Determination of shelf life of the product
    Annex H (normative) Steam exposure apparatus
    Annex I (normative) Determination of sensitivity of the indicator
            to the presence of air
    Annex J (normative) Air injection system
    Annex K (normative) Standard test pack
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials.

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

    Development Note Supersedes I.S. EN 867-3. (07/2007)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    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 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 5457:1999 Technical product documentation Sizes and layout of drawing sheets
    ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
    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
    EN 867-3:1997/AC:1998 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    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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