NF EN ISO 3826-1
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.
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.
<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>
<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>
- Avant-proposiv
- Introductionv
-
1 Domaine d'application1
-
2 Références normatives1
-
3 Termes et définitions1
-
4 Dimensions et désignation2
-
4.1 Dimensions2
-
4.2 Exemple de désignation2
-
5 Conception2
-
5.1 Généralités2
-
5.2 Contenu en air2
-
5.3 Évacuation sous pression2
-
5.4 Échantillons témoins3
-
5.5 Débit de prélèvement3
-
5.6 Tubulure(s) de prélèvement et de transfert5
-
5.7 Aiguille de prélèvement6
-
5.8 Raccord(s) de sortie6
-
5.9 Suspension6
-
6 Exigences7
-
6.1 Généralités7
-
6.2 Exigences physiques7
-
6.3 Exigences chimiques9
-
6.4 Exigences biologiques10
-
7 Suremballage10
-
8 Étiquetage10
-
8.1 Généralités10
-
8.2 Étiquetage de la poche en plastique11
-
8.3 Étiquetage du suremballage11
-
8.4 Étiquetage du conditionnement d'expédition11
-
8.5 Exigences concernant l'étiquette12
-
9 Solution anticoagulante et/ou solution de conservation12
- Annexe A (normative) Essais chimiques13
- Annexe B (normative) Essais physiques19
- Annexe C (normative) Essais biologiques21
- Bibliographie24
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ