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Norm
ÖNORM EN ISO 20186-2
Issue date: 2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic RNA (ISO 20186-2:2019)
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 27 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination 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 cell free circulating DNA, which are not described in this document.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
ÖNORM EN ISO 20186-2
2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Norm
↖
ONR CEN/TS 16835-2
2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel
ONR CEN/TS 16835-2
2015 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel Entwurf
Norm
Issue date :
2019 02 19
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
Norm
Issue date :
2012 11 05
Medical laboratories — Requirements for quality and competence