prEN ISO 3826-3 rev

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

General information

10.99 New project approved   Jan 11, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

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

2017/745

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

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 3826-3:2007

NOW

IN_DEVELOPMENT
prEN ISO 3826-3 rev
10.99 New project approved
Jan 11, 2024