scope:

This part of EN ISO 3826 specifies requirements, including performance requirements, for apheresis blood bag systems with integrated features. Apheresis blood bag systems need not contain all of the integrated features identified in this document. 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 (stem) cell storage bag; ? post collection sampling devices; ? 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.