NF EN 868-5
NF EN 868-5

NF EN 868-5

December 2018
Standard Current

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

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Main informations

Collections

National standards and national normative documents

Publication date

December 2018

Number of pages

25 p.

Reference

NF EN 868-5

ICS Codes

11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Print number

1

European kinship

EN 868-5:2018
Replaced standards (1)
NF EN 868-5
NF EN 868-5
September 2009
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 5 : sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

Le présent document fournit des méthodes d'essai et des valeurs relatives aux sachets et gaines thermoscellables et auto-scellables fabriqués à partir de matériaux poreux, conformément aux normes NF EN 868 Parties 2, 3, 6, 7, 9 ou 10, et en film plastique, conformément à l'Article 4. Ils sont utilisés comme systèmes de barrière stérile et/ou d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'à leur utilisation. Il présente uniquement les exigences de performance et les méthodes d'essai spécifiques des produits couverts par la présente partie de la NF EN 868 mais elle n'ajoute pas ou ne modifie pas les exigences générales spécifiées dans la NF EN ISO 11607-1. En conséquence, les exigences particulières dans les paragraphes 4.2 à 4.5 peuvent être utilisées pour démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de la NF EN ISO 11607-1. Les matériaux spécifiés dans la présente partie de l'EN 868 sont destinés exclusivement à un usage unique.

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