NF EN 868-7

NF EN 868-7

April 2025
Standard Current

Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods

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Main informations

Collections

National standards and national normative documents

Publication date

April 2025

Number of pages

33 p.

Reference

NF EN 868-7

ICS Codes

11.080.30   Sterilized packaging

Classification index

S98-051-7

Print number

1

European kinship

EN 868-7:2025
Replaced standards (1)
NF EN 868-7
March 2017
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods

Le présent document fournit des méthodes d'essai et des valeurs applicables au papier enduit d'adhésif de scellage, fabriqué à partir de papier conforme à la NF EN 868 6 et utilisé comme système de barrière stérile et/ou comme système d'emballage destiné à maintenir l'état de stérilité des dispositifs médicaux, stérilisés au stade terminal, jusqu'à leur utilisation. Les matériaux décrits dans le présent document sont destinés à un usage pour la stérilisation à l'oxyde d'éthylène ou par irradiation.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Exigences de performance et méthodes d'essai
  • 6 Compatibilité avec la stérilisation
  • 7 Étiquetage
  • 8 Informations à fournir
  • Annexe A Méthode de détermination de la résistance à l'eau
  • Annexe B Méthode de détermination de la taille de pore
  • Annexe C Méthode de détermination de la régularité des enductions adhésives de scellage sur du papier
  • Annexe D Méthode de détermination de la masse par unité de surface de papier non enduit et de couche adhésive
  • Annexe E Détermination de la force de scellage et du mode de rupture des éprouvettes
  • Annexe F Répétabilité et reproductibilité des méthodes d'essai
  • Annexe G Aspects environnementaux
  • Bibliographie
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