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DIN CEN ISO/TS 7552-3:2025-03

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024); German version CEN ISO/TS 7552-3:2024

Fecha edición: 2025-03-01
En Vigor
Idiomas disponibles: Alemán
Resumen: 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 performed and/or developed by medical laboratories, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research. It is also intended to be used by laboratory customers including health institutions requesting examinations for their patients as well as biobanks and regulatory authorities. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e. g. fetal cells). NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Keywords: Analysis methods|Biomedical|Blood|Blood counts|Blood taking|Blood tests|Cancer|Carcinoma research|Cells (biology)|Definitions|Diagnosis|In vitro|In-vitro diagnostic|Laboratories|Laboratory method|Laboratory tests|Medical sciences|Molecular structure|Original blood|Samples|Sampling methods|Specimen preparation|Storage|Transport|Venous blood
ICS: 11.100.10 - Sistemas de ensayo para diagnóstico in vitro
CTN:

Equivalencia Internacional

Idéntica CEN ISO/TS 7552-3:2024

Idéntica ISO/TS 7552-3:2024

Reemplazo Normas

Reemplaza a DIN CEN/TS 17390-3:2020-05

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