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ISO 3826-1:2019

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

Publication date:   Sep 15, 2019

General information

60.60 Standard published   Sep 15, 2019

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

Buying

Published

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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WITHDRAWN
ISO 3826-1:2013

NOW

PUBLISHED
ISO 3826-1:2019
60.60 Standard published
Sep 15, 2019

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 3826-1:2019/Amd 1:2023