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
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.
Legislation related to this standard
PUBLISHED
EN ISO 3826-3:2007
60.60
Standard published
Dec 12, 2007
IN_DEVELOPMENT
prEN ISO 3826-3 rev