DIN EN ISO 8871-5:2025-07
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025); German version EN ISO 8871-5:2025
| Fecha edición: |
2025-07-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4. |
| Keywords: | Blood transfusion equipment|Cannulas|Characterisations|Classification|Closures|Definitions|Designations|Drug administration|Drugs|Elastomers|Functions|Hypodermic needles|Identification|Infusions|Injection bottles|Injection instruments|Injections|Inspection|Marking|Materials|Means of packaging|Medical equipment|Medical sciences|Medical technology|Medicaments|Medicine|Packages|Parenteral infusion equipment|Performance requirements|Pharmaceutical technology|Preparation|Rubber|Rubber products|Sealing|Specification (approval)|Specifications|Sterilization (hygiene)|Storage|Testing|Transfusions|Vulcanized rubber |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 8871-5:2025 Idéntica ISO 8871-5:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 8871-5:2017-03 Reemplaza a DIN EN ISO 8871-5:2024-05 |
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