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EVS-EN ISO 3826-1:2019

Kokkupandavad inimvere ja verekomponentide plastkonteinerid. Tavakonteinerid

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Kehtiv alates 01.11.2019
Alusdokumendid
ISO 3826-1:2019; EN ISO 3826-1:2019
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
17.04.2023
Muudatus
01.11.2019
Põhitekst
05.08.2013
Põhitekst
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.

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