Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

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Main informations

Collections

National standards and national normative documents

Publication date

December 2018

Number of pages

15 p.

Reference

NF EN 868-9

ICS Codes

11.040.01 Medical equipment in general

11.080.30 Sterilized packaging

55.040 Packaging materials and accessories

Print number

European kinship

EN 868-9:2018

Replaced standards (1)

NF EN 868-9

September 2009

Standard Cancelled

Packaging materials for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods

Le présent document fournit des méthodes d'essai et des valeurs relatives aux matériaux non-tissés à base de polyoléfines, non enduits, utilisés dans des systèmes de barrière stérile préformés et/ou des systèmes 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 n'ajoute pas ou ne modifie pas les exigences générales spécifiées dans la norme NF EN ISO 11607-1. En conséquence, les exigences particulières dans les paragraphes 4.2 à 4.3 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 la NF EN 868 sont destinés exclusivement à un usage unique.

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