ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

Digital Document2015 edition2015Purchase Options

Referenced standards

EN 15986:2011ISO 10993-10:2010ISO 10993-11:2006ISO 10993-12:2012ISO 10993-1:2009ISO 10993-4:2002ISO 10993-5:2009ISO 1135-4:2012ISO 15223-1:2012ISO 15747ISO 3696:1987ISO 3826-1:2013ISO 3826-2:2008ISO 3826-3:2006ISO 594-2:1998ISO 8536-4:2010
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ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features

ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826.

The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid.

ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

Edition2015
Standard Part No4
Published Date2015
Published ByInternational Standardization Organisation
Page Count31