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ILNAS-EN ISO 3826-3:2007 Edition 12/2007
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
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Abstract

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). 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 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

Status

Standard - Active

Origin

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

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project      date of ratification (dor)    19/11/2007
end of the vote on the project      date of anouncement (doa)    31/03/2008
start of the vote on the final project    17/05/2007   date of publication (dop)    30/06/2008
end of the vote on the final project    17/10/2007   date of withdrawal (dow)    30/06/2008


Publication Official Journal
of the Grand-Duchy of Luxembourg
27/05/2008
Reference

Relations

Evolutions

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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