Abstract

This document specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document. 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, which specifies the requirements of conventional containers, this document specifies additional requirements for blood bag systems using multiple units. This document does not cover automated blood collection systems. Unless otherwise specified, all tests specified in this document apply to the plastic container as prepared ready for use.

Begin

2024-01-16

WI

00205396

Planned document number

DIN EN ISO 3826-3

Project number

17600070

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 3: Blood bag systems with integrated features (ISO 3826-3:2006); German version EN ISO 3826-3:2007
2008-03

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