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Norm
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 ce...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 25 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 20186-3
2020 03 15
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Norm
↖
ONR CEN/TS 16835-3
2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel
ONR CEN/TS 16835-3
2015 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel Entwurf
Norm
Issue date :
2012 11 05
Medical laboratories — Requirements for quality and competence
Norm
Issue date :
2019 09 25
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma