DIN EN ISO 3826-3:2026-03
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems and its integrated features (ISO/DIS 3826-3:2026); German and English version prEN ISO 3826-3:2026 / Note: Date of issue 2026-02-13*Intended as replacement for DIN EN ISO 3826-3 (2008-03).
| Fecha edición: |
2026-03-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document. The integrated features refer to: leucocyte filter; pre-donation sampling device; top-and-bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1, which specifies the requirements of conventional containers, this document specifies additional requirements for blood bag systems using multiple units. This document does not cover automated blood collection systems. Unless otherwise specified, all tests specified in this document apply to the plastic container as prepared ready for use. |
| Keywords: | Blood|Blood transfusions|Characteristics|Chemical properties|Components|Containers for blood|Definitions|Design|Dimensions|Labelling|Marking|Medical sciences|Packages|Physical properties|Plastic bags|Plastic containers|Polyvinyl chloride|Properties|PVC|Specification (approval)|Sterilized goods|Testing |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: |
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