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  • BSI
    BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
    Edition: 2019
    $435.35
    / user per year

Description of BS EN ISO 20186-1:2019 2019

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA 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 RNA and RNA in exosomes circulating in blood. These 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 cellular RNA therefrom.

RNA in pathogens present in blood is not covered by this document.



Standard NumberBS EN ISO 20186-1:2019
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
StatusUnder Review
Publication Date2019-04-02
ReplacesPD CEN/TS 16835-1:2015
Identical National Standard OfISO 20186-1, FprEN ISO 20186-1
DescriptorsMedical sciences, Management, Quality assurance systems, Laboratory testing, Medical laboratory equipment, Medical technology, Laboratories, Quality management, Quality assurance, Laboratory accreditation, Quality
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 90876 7
PublisherBSI
Pages30

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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