DIN EN ISO 1135-5:2023-11
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023); German and English version prEN ISO 1135-5:2023 / Note: Date of issue 2023-09-29
| Fecha edición: |
2026-06-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This document ensures compatibility with containers for blood and blood components as well as intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components. Platelet components should not be transfused under pressure using these sets. |
| Keywords: | Accessories|Biological tests|Blood transfusion equipment|Chemical properties|Compatibility|Definitions|Designations|Disposable|Disposables|Efficiency|Equipment for single use|Equipment safety|Labelling|Marking|Materials|Materials specification|Medical devices|Medical equipment|Medical products|Medical sciences|Packages|Physical properties|Physical testing|Power infusion|Power infusion apparatus|Properties|Safety of products|Safety requirements|Specification|Specification (approval)|Terms|Testing|Tightness |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Reemplazo Normas |
Es reemplazada por DIN EN ISO 1135-5:2026-06 |
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