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EN ISO 3826-3:2007

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

Publication date:   Dec 30, 2008

General information

60.60 Standard published   Dec 12, 2007

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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Life cycle

NOW

PUBLISHED
EN ISO 3826-3:2007
60.60 Standard published
Dec 12, 2007

REVISED BY

IN_DEVELOPMENT
prEN ISO 3826-3 rev

Relations

Adopted from ISO 3826-3:2006 IDENTICAL