60.60 Standard published Oct 16, 2019
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
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.
WITHDRAWN
EN ISO 3826-1:2013
PUBLISHED
EN ISO 3826-1:2019
60.60
Standard published
Oct 16, 2019
PUBLISHED
EN ISO 3826-1:2019/A1:2023
