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  • DIN EN 868-5:2009-09

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - 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    Superseded date:  02-03-2019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
          4.2.1 Poröses Material
          4.2.2 Kunststoff-Verbundfolie
      4.3 Konstruktion und Ausführung
      4.4 Prozessindikator
      4.5 Leistungsanforderungen und Prüfverfahren
      4.6 Kennzeichnung
          4.6.1 Klarsichtbeutel und -schläuche
          4.6.2 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
             Beständigkeit gegenüber dem vorgesehenen
             Sterilisationsverfahren
    Anhang C (normativ) Verfahren zur Bestimmung von
             feinen Löchern in der Kunststoff-Verbundfolie
    Anhang D (normativ) Verfahren zur Bestimmung der
             Festigkeit der Siegelnaht bei Klarsichtbeuteln
             und -schlauchmaterialien
    Anhang E (normativ) Verfahren zur Bestimmung der
             Peel-Merkmale von Papier/Kunststoff-Verbundmaterialien
    Anhang F (normativ) Verfahren zur Bestimmung der Faserrichtung
    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 Supersedes DIN 58953-4. (09/1999) DRAFT 2017 issued in August 2017. (08/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

    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)

    DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 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
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    EN 13060:2014 Small steam sterilizers
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