NF EN ISO 3826-1

NF EN ISO 3826-1

April 2004
Standard Cancelled

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

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. ISO 3826-1:2003 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 3826-1:2003 apply to the plastics container as prepared ready for use. ISO 3826-1:2003 is not applicable to plastics containers with an integrated filter.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2004

Number of pages

33 p.

Reference

NF EN ISO 3826-1

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-230-1

Print number

2 - 01/02/2006

International kinship

ISO 3826-1:2003

European kinship

EN ISO 3826-1:2003
Sumary
Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

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.

ISO 3826-1:2003 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 3826-1:2003 apply to the plastics container as prepared ready for use.

ISO 3826-1:2003 is not applicable to plastics containers with an integrated filter.

Replaced standards (2)
NF S90-230
September 1978
Standard Cancelled
Medical and surgical equipment. Transfusion apparatus for medical use. Physical and dimensional properties of simple flexible plastic bags for blood and its derivatives.

NF S90-231
December 1978
Standard Cancelled
Medical and surgical equipment. Transfusion apparatus for medical use. Physical and dimensional properties of multiple flexible plastic bags for blood and its derivates.

Standard replaced by (1)
NF EN ISO 3826-1
August 2013
Standard Cancelled
Plastics collapsible containers for human blood and blood components - Part 1 : conventional containers

<p>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.</p> <p>ISO 3826-1:2013 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 3826-1:2013 apply to the plastics container as prepared ready for use.</p>

Table of contents
View the extract
  • 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
    2
  • 5.5 Débit de prélèvement
    4
  • 5.6 Tubulure(s) de prélèvement et de transfert
    4
  • 5.7 Aiguille de prélèvement
    4
  • 5.8 Raccord(s) de sortie
    5
  • 5.9 Suspension
    5
  • 6 Exigences
    5
  • 6.1 Généralités
    5
  • 6.2 Exigences physiques
    5
  • 6.3 Exigences chimiques
    7
  • 6.4 Exigences biologiques
    8
  • 7 Suremballage
    9
  • 8 Étiquetage
    9
  • 8.1 Généralités
    9
  • 8.2 Étiquetage de la poche en plastique
    9
  • 8.3 Étiquetage du suremballage
    10
  • 8.4 Étiquetage du conditionnement d'expédition
    10
  • 8.5 Exigences concernant l'étiquette
    10
  • 9 Solution anticoagulante et/ou solution de conservation
    11
  • Annexe A (normative) Essais chimiques
    12
  • Annexe B (normative) Essais physiques
    18
  • Annexe C (normative) Essais biologiques
    19
  • Bibliographie
    23
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