ISO 3826-4:2015

This standard was last reviewed and confirmed in 2021. Therefore this version remains current.

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.

General information

Status
: Published

Publication date
: 2015-08
Edition
: 1

Number of pages
: 31
Technical Committee
: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
ICS
:
11.040.20 Transfusion, infusion and injection equipment

This standard contributes to the following Sustainable Development Goal:

Good Health and Well-being

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ISO 3826-4:2015

A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)

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