BS EN ISO 3826-4:2015 - Page 2

Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integrated features | Status: Current, Under review

1 Scope This part of ISO 3826 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.

This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated or semi-automated blood collection systems. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 3826.