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ILNAS-EN ISO 3826-4:2015 Edition 08/2015
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
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Abstract

ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826. 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 (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid. ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    10/10/2013   date of ratification (dor)    23/04/2015
end of the vote on the project    10/03/2014   date of anouncement (doa)    30/11/2015
start of the vote on the final project    22/01/2015   date of publication (dop)    29/02/2016
end of the vote on the final project    22/03/2015   date of withdrawal (dow)    29/02/2016


Publication Official Journal
of the Grand-Duchy of Luxembourg
31/12/2015
Reference Mémorial A N° 264

Relations

Relations to international standards
ISO 3826-4 
ISO 3826-4:2015 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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