ISO 3826-1:2019

Published (Edition 3, 2019)

This standard has 1 amendment.

ISO 3826-1:2019

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Abstract

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.

General information

Status
: Published

Publication date
: 2019-09

Stage
: Close of review [90.60]
Edition
: 3

Number of pages
: 23
Technical Committee :
ISO/TC 76

ICS :
11.040.20
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Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.