Norm

NEN-EN-ISO 20186-3:2019 en

Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 3: Geïsoleerd circulerend cel vrij DNA

88,37 96,32 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 17
Commissie In vitro diagnostica
Gepubliceerd op 01-11-2019
Taal Engels
NEN-EN-ISO 20186-3 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.

Details

ICS-code 11.100.10
Nederlandse titel Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 3: Geïsoleerd circulerend cel vrij DNA
Engelse titel Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
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