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BS PD CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
standard by BSI Group, 01/24/2020
Full Description
This document gives guidelines on the handling, storage, processing and documentation of venouswhole blood specimens intended for the examination of human DNA isolated from circulating tumourcells (CTCs) during the pre-examination phase before a molecular examination is performed.This document is applicable to molecular in vitro diagnostic examinations including laboratorydeveloped tests performed by medical laboratories. It is also intended to be used by laboratorycustomers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercialorganizations performing biomedical research, and regulatory authorities.Cross References:
EN ISO 15189:2012
ISO 15189:2012
ISO 15190
EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS
ISO/IEC 17020:2012
All current amendments available at time of purchase are included with the purchase of this document.
M00011528
2021-02-16
New product
BS PD CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
standard by BSI Group, 01/24/2020