EN ISO 3826-1:2019

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

Publication date:   Feb 14, 2020

General information

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

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 3826-1:2013

NOW

PUBLISHED
EN ISO 3826-1:2019
60.60 Standard published
Oct 16, 2019

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 3826-1:2019/A1:2023