40.60 Close of voting May 4, 2026
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Draft
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
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
EN ISO 3826-3:2007
IN_DEVELOPMENT
prEN ISO 3826-3
40.60
Close of voting
May 4, 2026
