SS-EN-ISO-3826-4 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

SS-EN-ISO-3826-4 - 2015 EDITION - CURRENT


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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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)


Medical devices

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Designation Name

SS-EN ISO 3826-4:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Aug. 23, 2015

Language(s)

English

Page Count

52

International Equivalent

EN ISO 3826-4:2015(IDT); ISO 3826-4:2015(IDT)