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Technische Regel
ONR CEN/TS 17390-3
Issue date: 2020 05 01
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 (CEN/TS 17390-3:2020)
This document specifies guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for staining of circulating tumou...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 23 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for staining of circulating tumour 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 pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
ONR CEN/TS 17390-3
2020 05 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circul...
Technische Regel
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ONR CEN/TS 17390-3
2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circul...
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