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EN ISO 3826-1:2013

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) EN ISO 3826-1:2013

Publication date:   Jul 15, 2013

General information

99.60 Withdrawal effective   Oct 16, 2019

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 3826-1:2013 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 3826-1:2003

NOW

WITHDRAWN
EN ISO 3826-1:2013
99.60 Withdrawal effective
Oct 16, 2019

REVISED BY

PUBLISHED
EN ISO 3826-1:2019