Standard CEN/TS 17390-3:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
Publication date
11.100.10 In vitro diagnostic test systems
Summary :
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cel
l) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical stainin
g) of CTCs during the pre-examination Phase before the cytopathological evaluation 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 specific staining procedures. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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