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Norm
ÖNORM EN ISO 3826-1
Issue date: 2020 02 01
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 32 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 3826-1
2020 02 01
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...
Norm
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ÖNORM EN ISO 3826-1
2013 09 01
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...
Norm
ÖNORM EN ISO 3826-1
2004 03 01
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...
Norm
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1987 04 09
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ISO 10993-11:2017
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2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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ISO 3826-1:2019
Issue date :
2019 09 15
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers