• NF EN 868-5 : 2009

    Current The latest, up-to-date edition.

    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): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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

    Avant-propos
    Introduction
    1 Domaine d'application
    2 Références normatives
    3 Termes et définitions
    4 Exigences
    5 Informations à fournir par le fabricant
    Annexe A (informative) - Précisions relatives aux
             modifications techniques significatives
             apportées à la présente Norme européenne
             par rapport à l'édition précédente
    Annexe B (normative) - Méthode de détermination de la
             résistance au procédé de stérilisation prévu
    Annexe C (normative) - Méthode de détermination des
             piqûres dans un film stratifié plastique
    Annexe D (normative) - Méthode de détermination de la
             résistance du scellage pour des sachets et
             un matériau gaine
    Annexe E (normative) - Méthode de détermination des
             caractéristiques de pelabilité de papier/film
             plastique complexé
    Annexe F (normative) - Méthode de détermination de
             l'orientation des fibres
    Bibliographie

    Abstract - (Show below) - (Hide below)

    Gives examples of requirements and test procedures for heat and self-sealable pouches and reels made from paper which complies with EN 868-3 and plastic film. Defined are those suitable for use as packaging for medical devices which are to be terminally sterilized.

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

    Development Note Indice de classement: S98-051-5PR. (01/2002) PR NF EN 868-5 December 2007. (12/2007) PR NF EN 868-5 October 2017. (11/2017)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Current

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

    EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
    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 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
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