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Normas DIN – AENOR
DIN CEN/TS 17390-2:2020-05

DIN CEN/TS 17390-2:2020-05

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

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTCs) dans le sang total veineux - Partie 2: ADN extrait; Version allemande CEN/TS 17390-2:2020

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben - Teil 2: Isolierte DNA; Deutsche Fassung CEN/TS 17390-2:2020

Fecha:
2020-05 /Active
Equivalencias internacionales:

CEN/TS 17390-2 (2020-01)

Resumen:
This document gives guidelines on the handling, storage, processing and documentation of venous blood specimens intended for the examination of human DNA isolated from Circulating Tumor 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 specific blood cells and subsequent isolation of genomic DNA there from. DNA in pathogens present in blood is not covered by this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Keywords:
Analysis, Analysis methods, Blood, Blood cells, Blood counts, Blood taking, Cancer, Cells (biology), Definitions, Deoxyribonucleic acid, Diagnosis, DNA, Investigations, In-vitro diagnostic, Laboratories, Laboratory method, Measurement, Measuring techniques, Medical sciences, Molecular structure, Neoplasms, Original blood, Personal health, Research methods, Sample preparation, Samples, Transport, Venous blood
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