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ÖNORM EN ISO 20186-3

Issue date: 2020 03 15

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. DNA in pathogens present in blood is not covered by this document.

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General information on ÖNORM EN ISO 20186-3

Format

Digital | 25 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 20186-3 from 2015 til today.

• ÖNORM EN ISO 20186-3

  2020 03 15 Standard ÖNORM EN ISO 20186-3, Edition: 2020 03 15

  Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous...
• ONR CEN/TS 16835-3

  2015 12 15 Technische Regel ONR CEN/TS 16835-3, Edition: 2015 12 15

  Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...

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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 15189:2012	Titel Medical laboratories — Requirements for quality and competence	Ausgabedatum 2012 11 05	Art Standard	Zur Produktseite

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