Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO/DIS 3826-4:2026)

Comment end date 2026-04-21

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2026-02-20 till 2026-04-21

4. Closure of enquiry

5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.040.20 - Transfusion, infusion and injection equipment

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 205

Number of comments

Comment start date

2026-02-20

Scope

This document 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 document 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.

Relations

Pakeis

prEN ISO 3826-4