BS EN ISO 3826-1:2019 - Plastics collapsible containers for human blood and blood components. Conventional containers

BS EN ISO 3826-1:2019

Plastics collapsible containers for human blood and blood components. Conventional containers

Status : Current   Published : October 2019

Format
PDF

Format
HARDCOPY



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.

This document 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 this document apply to the plastics container as prepared ready for use.

This document is not applicable to plastics containers with an integrated filter.




Standard NumberBS EN ISO 3826-1:2019
TitlePlastics collapsible containers for human blood and blood components. Conventional containers
StatusCurrent
Publication Date25 October 2019
Normative References(Required to achieve compliance to this standard)ISO 1135-4, ISO 10993-10, ISO 1135-5, ISO 3696, ISO 10993-11, ISO 10993-4, ISO 10993-5
Informative References(Provided for Information)ISO 3826-4, ISO/TS 23128, ISO 9626, ISO 10993 (all parts), ISO 3826-3, DIN 13097-5, ISO 3826-2, DIN 13097-4, EN 15986, ISO 15223-1, ISO 15747:2018
ReplacesBS EN ISO 3826-1:2013
International RelationshipsEN ISO 3826-1:2019,ISO 3826-1:2019
Draft Superseded By18/30357483 DC
DescriptorsTubing (medical), Blood, Collapsible, Plastics, Performance testing, Storage, Containers, Packaging, Medical equipment, Performance, Blood transfusion equipment, Sterile equipment, Mechanical testing
ICS11.040.20
Title in FrenchPoches en plastique souple pour le sang et les composants du sang Poches conventionnelles
Title in GermanKunststoffbeutel für menschliches Blut und Blutbestandteile Konventionelle Beutel
CommitteeCH/212
ISBN978 0 580 97796 1
PublisherBSI
FormatA4
DeliveryYes
Pages38
File Size2.354 MB
Price£214.00


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