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  • BSI
    BS EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
    Edition: 2019
    $435.35
    / user per year

Description of BS EN ISO 20186-3:2019 2019

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. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

Standard NumberBS EN ISO 20186-3:2019
TitleMolecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
StatusUnder Review
Publication Date2019-11-27
ReplacesPD CEN/TS 16835-3:2015
Identical National Standard OfISO 20186-3:2019, EN ISO 20186-3:2019
CorrectsBS EN ISO 20186-3:2019
DescriptorsQuality assurance, Laboratory testing, Laboratory accreditation, Medical technology, Laboratories, Medical laboratory equipment, Quality management, Quality, Management, Cells (biology), Deoxyribonucleic acid, Medical sciences, Blood plasma, Quality assurance systems
ICS11.100.10 In vitro diagnostic test systems, 11.100.30 Analysis of blood and urine
CommitteeCH/212
ISBN978 0 539 12203 9
PublisherBSI
Pages26

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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