NF EN 868-8
NF EN 868-8

NF EN 868-8

December 2018
Standard Current

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

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Main informations

Collections

National standards and national normative documents

Publication date

December 2018

Number of pages

24 p.

Reference

NF EN 868-8

ICS Codes

11.040.01   Medical equipment in general
11.080.30   Sterilized packaging
55.040   Packaging materials and accessories

Print number

1

European kinship

EN 868-8:2018
Replaced standards (1)
NF EN 868-8
NF EN 868-8
October 2009
Standard Cancelled
Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Le présent document fournit des méthodes d'essai et des valeurs relatives aux conteneurs réutilisables employés comme systèmes de barrière stérile préformés destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'à leur utilisation. Ces conteneurs sont destinés à être utilisés dans les stérilisateurs à la vapeur d'eau, conformément à la NF EN 285. Il présente uniquement les exigences de performance et les méthodes d'essai spécifiques des produits couverts par le présent document mais il 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.

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