NF EN ISO 3826-4

NF EN ISO 3826-4

October 2015
Standard Current

Plastics collapsible containers for human blood and blood components - Part 4 : aphaeresis blood bag systems with integrated features

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.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2015

Number of pages

48 p.

Reference

NF EN ISO 3826-4

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-230-4

Print number

1

International kinship

European kinship

EN ISO 3826-4:2015
Sumary
Plastics collapsible containers for human blood and blood components - Part 4 : aphaeresis blood bag systems with integrated features

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.

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Dimensions
  • 5 Conception
  • 6 Exigences
  • 7 Suremballage
  • 8 Étiquetage
  • 9 Solution anticoagulante et/ou solution de conservation
  • Annexe A Essais chimiques
  • Annexe B Essais physiques
  • Annexe C Essais biologiques
  • Bibliographie
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