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    I.S. EN 868-2:2017

    Current The latest, up-to-date edition.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - 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
    5 Information to be supplied by the manufacturer
    Annex A (informative) - Details of significant technical
            changes between this European Standard and the
            previous edition
    Annex B (informative) - Method for the determination
            of drape
    Annex C (normative) - Method for the determination
            of water repellency
    Annex D (normative) - Method for the determination
            of pore size
    Annex E (informative) - Repeatability and reproducibility
            of test methods
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines test methods and values for materials for 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)

    EN ISO 13937-1:2000/AC:2006 Textiles - Tear properties of fabrics - Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 13937-1:2000/Cor.1:2004)
    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 13937-1:2000 Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic pendulum method (Elmendorf)
    EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
    ISO 6588-2:2012 Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction
    ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
    ISO 9073-3:1989 Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and elongation
    EN 1149-1:2006 Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity
    EN ISO 9073-9:2008 Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient (ISO 9073-9:2008)
    EN ISO 535:2014 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014)
    EN ISO 9237 : 1995 TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
    ISO 2758:2014 Paper Determination of bursting strength
    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 9073-9:2008 Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient
    ISO 1924-2:2008 Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min)
    EN 29073-3:1992 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
    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)
    EN ISO 13938-1 : 1999 TEXTILES - BURSTING PROPERTIES OF FABRICS - PART 1: HYDRAULIC METHOD FOR DETERMINATION OF BURSTING STRENGTH AND BURSTING DISTENSION
    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
    EN 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
    ISO 536:2012 Paper and board Determination of grammage
    ISO 3689:1983 Paper and board — Determination of bursting strength after immersion in water
    ISO 811:1981 Textile fabrics Determination of resistance to water penetration Hydrostatic pressure test
    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 13938-1:1999 Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension
    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 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 9198:2001 Paper, board and pulp Determination of water-soluble sulfates
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