DIN EN 868-2:2024-05
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2024 / Note: Date of issue 2024-04-12
| Fecha de anulación: |
2025-09-01
Anulada
|
|---|---|
| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This part of EN 868 provides test methods and values for materials 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 or modify the general requirements specified in EN ISO 11607-1. This document specifies test methods and values for sterilization wrap made of - single-use creped paper - single-use nonwoven materials - reusable woven textile materials 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 specifies materials, test methods and values that are specific to the products covered by this document. |
| Keywords: | Applications|Hygiene|Inspection|Marking|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Packages|Packaging|Packaging material|Packaging tests|Performance requirements|Products|Safety|Safety requirements|Specification (approval)|Sterilization (birth control)|Sterilization (hygiene)|Sterilized goods|Sterilizers|Storage|Testing|Transport packing|Validation |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
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Reemplazo Normas |
Es reemplazada por DIN EN 868-2:2025-09 |
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