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Normas DIN – AENOR
DIN EN ISO 20186-2:2017-02

DIN EN ISO 20186-2:2017-02

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO/DIS 20186-2:2016); German and English version prEN ISO 20186-2:2016 / Note: Date of issue 2017-01-13

Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang total veineux - Partie 2: ADN génomique extrait (ISO/DIS 20186-2:2016); Version allemande et anglaise prEN ISO 20186-2:2016 / Attention: Date de parution 2017-01-13

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 2: Isolierte genomische DNA (ISO/DIS 20186-2:2016); Deutsche und Englische Fassung prEN ISO 20186-2:2016 / Achtung: Erscheinungsdatum 2017-01-13

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

ISO/DIS 20186-2 (2016-12)

prEN ISO 20186-2 (2016-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 20186-2:2019-08

Resumen:
This Draft International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular assay is performed. This document covers specimens collected in venous whole blood collection tubes. This Draft International Standard 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, as well as institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. This Draft International Standard describe not: - different dedicated measures need to be taken for stabilizing blood cell free circulating DNA; - different dedicated measures need to be 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; - the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom; - DNA in pathogens present in blood. Circulating cell free DNA in blood is covered in ISO 20186-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Keywords:
Analysis, Analysis methods, Blood, Blood counts, Blood taking, Cells (biology), Definitions, Deoxyribonucleic acid, Diagnosis, DNA, Investigations, In-vitro diagnostic, Laboratories, Laboratory method, Measurement, Measuring techniques, Medical sciences, Molecular structure, Original blood, Personal health, Research methods, Sample preparation, Samples, Transport, Venous blood
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