Standard Technical specification · SIS-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

Status: Valid

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Standard Technical specification · SIS-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
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Scope
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 preexamination 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.
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.

Subjects

In vitro diagnostic test systems (11.100.10)


Buy this standard

Standard Technical specification · SIS-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
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Price: 833 SEK
standard ikon pdf

PDF

Price: 833 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80019551

Edition: 1

Approved: 2/7/2020

No of pages: 24