60.60 Standard published Oct 23, 2019
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.10 In vitro diagnostic test systems
Published
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.
WITHDRAWN
CEN/TS 16835-3:2015
PUBLISHED
EN ISO 20186-3:2019
60.60
Standard published
Oct 23, 2019
