Abstract / 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.