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    I.S. EN 868-3:2017

    Current The latest, up-to-date edition.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    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)

    National Foreword
    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    Annex A (informative) - Details of significant technical
            changes between this European Standard and the
            previous edition
    Annex B (normative) - Method for the determination
            of water repellency
    Annex C (normative) - Method for the determination
            of pore size
    Annex D (informative) - Repeatability and reproducibility
            of test methods
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

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

    ISO 1974:2012 Paper — Determination of tearing resistance — Elmendorf method
    ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 6588-2:2012 Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
    EN ISO 535:2014 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014)
    ISO 2758:2014 Paper Determination of bursting strength
    ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
    EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
    ISO 9197:2016 Paper, board and pulps Determination of water-soluble chlorides
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN ISO 1924-2:2008 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
    EN ISO 536:2012 Paper and board - Determination of grammage (ISO 536:2012)
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 1924-2:2008 Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min)
    EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
    ISO 2470-2:2008 Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness)
    ISO 3781:2011 Paper and board — Determination of tensile strength after immersion in water
    ISO 536:2012 Paper and board Determination of grammage
    ISO 3689:1983 Paper and board — Determination of bursting strength after immersion in water
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    EN ISO 2758:2014 Paper - Determination of bursting strength (ISO 2758:2014)
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 535:2014 Paper and board — Determination of water absorptiveness — Cobb method
    ISO 9198:2001 Paper, board and pulp Determination of water-soluble sulfates
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