prSRPS EN ISO 3826-3:2024

Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

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 directives

Directives related to this standard.