DIN EN 868-5:2026-02
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods; German and English version prEN 868-5:2026 / Note: Date of issue 2026-01-09*Intended as replacement for DIN EN 868-5 (2019-03).
| Fecha edición: |
2026-02-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document. |
| Keywords: | Applications|Bag foil|Bags|Dimensions|Disposable|Equipment for single use|Flexible pipes|Flexible plastics tube packaging|Goods|Heat-sealing|Heat-sealing materials|Hygiene|Inspection|Laminated foils|Marking|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Packages|Packaging material|Packaging tests|Paper|Paper bags|Plastic bags|Plastic films|Plastics|Porous|Porous materials|Production|Products|Safety|Safety requirements|Sealing|Sealing processes|Seals|Sequence of operations|Specification (approval)|Sterilization (birth control)|Sterilization (hygiene)|Sterilization papers|Sterilized goods|Sterilizers|Storage|Tear tests|Testing|Tolerances (measurement)|Transparent packages|Transparent sterilizing packing|Transport packing|Use|Validation |
| ICS: | 11.080.30 - Envases estériles |
| CTN: |
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