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  • UNI 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): 

    Language(s): 

    Published date:  03-09-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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)

    Committee CT 44
    Development Note Supersedes UNI EN 867-3. (10/2007)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    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
    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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