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STANDARD

Current

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)

There are 1 addition(s) to this standard

Document Number	Title	Link
Document Number ÖNORM EN ISO 3826-1/A1	Title Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers(ISO 3826-1:2019/Amd1:2023) (Amendment)

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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General information on ÖNORM EN ISO 3826-1

Format

Digital | 32 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 3826-1 from 2004 til today.

• ÖNORM EN ISO 3826-1

  2020 02 01 Standard ÖNORM EN ISO 3826-1, Edition: 2020 02 01

  Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...
• ÖNORM EN ISO 3826-1

  2013 09 01 Standard ÖNORM EN ISO 3826-1, Edition: 2013 09 01

  Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...
• ÖNORM EN ISO 3826-1

  2004 03 01 Standard ÖNORM EN ISO 3826-1, Edition: 2004 03 01

  Plastics collapsible containers for human blood and blood components - Part 1: Conventional containe...

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 10993-11:2017	Titel Biological evaluation of medical devices — Part 11: Tests for systemic toxicity	Ausgabedatum 2017 09 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-4:2017	Titel Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood	Ausgabedatum 2017 04 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-5:2009	Titel Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity	Ausgabedatum 2009 05 20	Art Standard	Zur Produktseite
Dokumentnummer ISO 1135-4	Titel Transfusion equipment for medical use - Part 4: Transfusion for single use	Ausgabedatum 1998 05	Art Standard	Zur Produktseite
Dokumentnummer ISO 1135-5:2015	Titel Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus	Ausgabedatum 2015 11 30	Art Standard	Zur Produktseite
Dokumentnummer ISO 3696:1987	Titel Water for analytical laboratory use — Specification and test methods	Ausgabedatum 1987 04 09	Art Standard	Zur Produktseite

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