Standard

NEN-EN-ISO 20186-1:2019 en

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA 

118,48 129,14 Incl BTW

About norm

Status Current
Number of pages 28
Committee In vitro diagnostica
Published on 01-04-2019
Language English
NEN-EN-ISO 20186-1 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.

Details

ICS-code 11.100.10
Dutch title Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 1: Geïsoleerd cellulair RNA.
English title Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA 

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