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Normas DIN – AENOR
DIN EN 868-3:2017-05

DIN EN 868-3:2017-05

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; German version EN 868-3:2017

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Papier utilisé dans la fabrication des sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) - Exigences et méthodes d'essai; Version allemande EN 868-3:2017

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und Prüfverfahren; Deutsche Fassung EN 868-3:2017

Fecha:
2017-05 /Active
Equivalencias internacionales:

EN 868-3 (2017-02)

Relación con otras normas DIN:

Reemplaza a: DIN EN 868-3:2015-08

Reemplaza a: DIN EN 868-3:2009-09

Resumen:
This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Keywords:
Bags, Disposable, Equipment for single use, Flexible pipes, Hygiene, Inspection, Marking, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Packages, Packaging material, Packaging tests, Paper, Paper bags, Products, Safety, Safety requirements, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Testing, Transparent packages, Transparent sterilizing packing, Transport packing, Validation
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