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Normas DIN – AENOR
DIN EN 868-4:2017-05

DIN EN 868-4:2017-05

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4: Sacs en papier - Exigences et méthodes d'essai; Version allemande EN 868-4:2017

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 4: Papierbeutel - Anforderungen und Prüfverfahren; Deutsche Fassung EN 868-4:2017

Fecha:
2017-05 /Active
Equivalencias internacionales:

EN 868-4 (2017-02)

Relación con otras normas DIN:

Reemplaza a: DIN EN 868-4:2015-08

Reemplaza a: DIN EN 868-4:2009-09

Resumen:
This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of this standard 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 to 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Keywords:
Applications, Bags, Disposable, Equipment for single use, Hygiene, Inspection, Marking, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Packages, Packaging material, Packaging tests, Paper, Paper bags, pH, Products, Safety, Safety requirements, Sealing, Specification (approval), Sterile supply, Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Storage, Tensile strength, Testing, Transport packing, Validation
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