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NF EN 868-5 : 2009

Current

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

Published date

12-01-2013

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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

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.

DevelopmentNote
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)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

Standards Relationship
EN 868-5:2009 Identical
BS EN 868-5:2009 Identical
NEN EN 868-5 : 2009 Identical
I.S. EN 868-5:2009 Identical
NBN EN 868-5 : 2009 Identical
DIN EN 868-5:2009-09 Identical
NS EN 868-5 : 2009 Identical
EN 868-5:2018 Identical
UNE-EN 868-5:2009 Identical

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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