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Technische Regel

ONR CEN/TS 17390-2

Issue date: 2020 05 01

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA (CEN/TS 17390-2:2020)

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated f...
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Publisher:
Austrian Standards International
Format:
Digital | 34 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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. This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA. This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
ONR CEN/TS 17390-2
2020 05 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circul...
Technische Regel
ONR CEN/TS 17390-2
2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circul...
Technische Regel Entwurf
Norm
ISO 15190:2020
Issue date : 2020 02 24
Medical laboratories — Requirements for safety