EVS-EN ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

General information
Valid from 02.09.2015
Base Documents
ISO 3826-4:2015; EN ISO 3826-4:2015
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

This part of EN ISO 3826 specifies requirements, including performance requirements, for apheresis blood bag systems with integrated features. Apheresis blood bag systems need not contain all of the integrated features identified in this document.
The integrated features refer to:
needle stick protection device;
leucocyte filter;
sterile barrier filter;
pre-collection sampling device;
red blood cell storage bag;
plasma storage bag;
platelet storage bag;
polymorphonucleic (stem) cell storage bag;
post collection sampling devices;
connections for storage solutions, anticoagulant and replacement fluid.
This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated or semi-automated blood collection systems.
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