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  • DIN EN 868-10:2009-09

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-03-2019

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Anforderungen
      4.1 Allgemeines
      4.2 Materialien
      4.3 Leistungsanforderungen und Prüfverfahren
      4.4 Kennzeichnung der Schutzverpackung
    5 Vom Hersteller bereitzustellende Angaben
    Anhang A (informativ) Angaben über wesentliche
             technische Änderungen zwischen dieser
             Europäischen Norm und der Vorgängerausgabe
    Anhang B (normativ) Verfahren zur Bestimmung der
             flächenbezogenen Masse von unbeschichteten
             Vliesstoffen aus Polyolefinen und der
             Klebemittelschicht
    Anhang C (normativ) Verfahren zur Bestimmung der
             Siegelfestigkeit und optische Prüfung der
             Klebemittelschicht
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 263 and 265.

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

    Development Note DRAFT 2017 issued in August 2017. (08/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN HDBK 265 : 2ED 2012 STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE

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

    ISO 1974:2012 Paper — Determination of tearing resistance — Elmendorf method
    DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    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
    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
    EN 21974 : 1994 PAPER - DETERMINATION OF TEARING RESISTANCE (ELMENDORF METHOD)
    ISO 2758:2014 Paper Determination of bursting strength
    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)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 536:2012 Paper and board Determination of grammage
    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
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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