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DIN Standards Committee Health Technologies

Abstract

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.

Begin

2024-01-16

WI

00205397

Planned document number

DIN EN ISO 3826-4 rev

Project number

17600071

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment  

previous edition(s)

Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015); German version EN ISO 3826-4:2015
2015-12