DIN EN 868-4:2025-09
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2025
| Fecha edición: |
2025-09-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | The EN 868 series of standards have been developed mainly for materials and sterile barrier systems used in health care facilities sterilization processes. The EN 868 series of standards can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1. Considering CEN guide 4 and the CEN environmental checklists, this revision has been complemented with a new annex with guidance to encourage users to also include environmental aspects when applying the EN 868 series of standards with the objective to minimize the environmental impact. Environmental aspects have also been included into the description of test methods with the same objective. This document has been prepared by Working Committee NA176-03-07AA "Sterile supply" of DIN Standards Committee Health Technologies. |
| 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 |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 868-4:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN 868-4:2017-05 Reemplaza a DIN EN 868-4:2024-05 |
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