DIN EN ISO 8536-15:2023-06
Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022 + Amd 1:2023); German version EN ISO 8536-15:2022 + A1:2023
| Fecha edición: |
2023-06-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets"). This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets. |
| Keywords: | Bioassay|Biological tests|Chemical properties|Compatibility|Definitions|Density|Designations|Disposable|Equipment for single use|Gravity-fed infusion|Guide books|Infusions|Inspection|Labelling|Light|Light-fastness|Liquids|Marking|Materials|Medical devices|Medical equipment|Medical products|Medical sciences|Packages|Parenteral infusion equipment|Performance|Physical properties|Properties|Protection|Quality requirements|Safety|Safety requirements|Specification|Specification (approval)|Testing|Tightness|Volume flow rate |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 8536-15:2022/A1:2023 Idéntica ISO 8536-15:2022/Amd 1:2023 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 8536-15:2022-06 Reemplaza a DIN EN ISO 8536-15/A1:2022-09 |
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