DIN EN 868-10:2019-03
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018 / Note: To be replaced by DIN EN 868-10 (2026-02).
| Fecha edición: |
2019-03-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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.NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.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.NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e. g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.The materials specified in this part of EN 868 are intended for single use only. |
| Keywords: | Adhesive|Adhesive film|Adhesives|Applications|Bag foil|Bags|Coated|Coated materials|Coatings|Disposable|Disposables|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 cloth|Non-woven fabrics|Packages|Packages containers|Packaging material|Packaging tests|Performance requirements|Plastics|Polyolefins|Production|Products|Safety|Safety requirements|Specification (approval)|Sterilization (birth control)|Sterilization (hygiene)|Sterilized goods|Sterilizers|Storage|Tear tests|Testing|Transparent sterilizing packing|Transport packing|Validation |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 868-10:2018 |
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Reemplazo Normas |
Reemplaza a DIN EN 868-10:2009-09 Reemplaza a DIN EN 868-10:2017-08 |
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