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Normas DIN – AENOR
DIN EN 868-10:2009-09

DIN EN 868-10:2009-09

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2009

Matériaux d´emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 10 : Non tissés à base de polyoléfines, enduits d'adhésif, pour la fabrication de sachets, gaines et opercules thermoscellables - Exigences et méthodes d'essai; Version allemande EN 868-10:2009

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 10: Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und Prüfverfahren; Deutsche Fassung EN 868-10:2009

Fecha Anulación:
2019-03 /Withdrawn
Equivalencias internacionales:

EN 868-10 (2009-05)

Relación con otras normas DIN:

Reemplazada por: DIN EN 868-10:2019-03

Reemplaza a: DIN EN 868-10:2000-03

Reemplaza a: DIN EN 868-10:2007-10

Resumen:
This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for 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 nor modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Keywords:
Adhesive, Adhesive film, Adhesives, Applications, Bag foil, Bags, Coated, Disposable, Equipment for single use, Flexible pipes, Flexible plastics tube packaging, Heat-sealing materials, Hygiene, Inspection, Laminated foils, Lids, Marking, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Non-woven fabrics, Packages, Packages containers, Packaging material, Packaging tests, Plastics, Polyolefins, Production, Products, Safety, Safety requirements, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Storage, Testing, Transparent sterilizing packing, Transport packing, Validation
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