EN ISO 3826-1:2003

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003) EN ISO 3826-1:2003

Publication date:   Jul 30, 2004

General information

99.60 Withdrawal effective   Jun 5, 2013

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

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.

Life cycle

NOW

WITHDRAWN
EN ISO 3826-1:2003
99.60 Withdrawal effective
Jun 5, 2013

REVISED BY

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EN ISO 3826-1:2013