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
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.
Legislation related to this standard
WITHDRAWN
EN ISO 3826-1:2003
WITHDRAWN
EN ISO 3826-1:2013
99.60
Withdrawal effective
Oct 16, 2019
PUBLISHED
EN ISO 3826-1:2019