CEN/TS 17390-1:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

Publication date:   Aug 17, 2020

General information

60.60 Standard published   Jan 22, 2020


CEN/TC 140 In vitro diagnostic medical devices

Technical Specification

11.100.10   In vitro diagnostic test systems



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This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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.
This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1.
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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Life cycle


CEN/TS 17390-1:2020
60.60 Standard published
Jan 22, 2020


prCEN ISO/TS 7552-1