NF EN ISO 3826-1

NF EN ISO 3826-1

August 2013
Standard Cancelled

Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged. ISO 3826-1:2013 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in ISO 3826-1:2013 apply to the plastics container as prepared ready for use.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2013

Number of pages

36 p.

Reference

NF EN ISO 3826-1

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-230-1

Print number

1 - 26/07/2013

International kinship

European kinship

EN ISO 3826-1:2013
Sumary
Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.

ISO 3826-1:2013 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.

Unless otherwise specified, all tests specified in ISO 3826-1:2013 apply to the plastics container as prepared ready for use.

Replaced standards (1)
NF EN ISO 3826-1
April 2004
Standard Cancelled
Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

<p>ISO 3826-1:2003 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle and with optional transfer tube(s), for the collection, storage, processing, transport, separation and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.</p> <p>ISO 3826-1:2003 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple or multiple units.</p> <p>Unless otherwise specified, all tests specified in ISO 3826-1:2003 apply to the plastics container as prepared ready for use.</p> <p>ISO 3826-1:2003 is not applicable to plastics containers with an integrated filter. </p>

Standard replaced by (1)
NF EN ISO 3826-1
October 2019
Standard Current
Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

<p>This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.</p> <p>This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.</p> <p>Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.</p> <p>This document is not applicable to plastics containers with an integrated filter.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Dimensions et désignation
    2
  • 4.1 Dimensions
    2
  • 4.2 Exemple de désignation
    2
  • 5 Conception
    2
  • 5.1 Généralités
    2
  • 5.2 Contenu en air
    2
  • 5.3 Évacuation sous pression
    2
  • 5.4 Échantillons témoins
    3
  • 5.5 Débit de prélèvement
    3
  • 5.6 Tubulure(s) de prélèvement et de transfert
    5
  • 5.7 Aiguille de prélèvement
    6
  • 5.8 Raccord(s) de sortie
    6
  • 5.9 Suspension
    6
  • 6 Exigences
    7
  • 6.1 Généralités
    7
  • 6.2 Exigences physiques
    7
  • 6.3 Exigences chimiques
    9
  • 6.4 Exigences biologiques
    10
  • 7 Suremballage
    10
  • 8 Étiquetage
    10
  • 8.1 Généralités
    10
  • 8.2 Étiquetage de la poche en plastique
    11
  • 8.3 Étiquetage du suremballage
    11
  • 8.4 Étiquetage du conditionnement d'expédition
    11
  • 8.5 Exigences concernant l'étiquette
    12
  • 9 Solution anticoagulante et/ou solution de conservation
    12
  • Annexe A (normative) Essais chimiques
    13
  • Annexe B (normative) Essais physiques
    19
  • Annexe C (normative) Essais biologiques
    21
  • Bibliographie
    24
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