STN P CEN/TS 17390-3
| Name: | STN P CEN/TS 17390-3 |
| Validity: | Withdrawn |
| Number of pages: | 20 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Molekulárno-diagnostické vyšetrenia in vitro. Špecifikácie predbežných vyšetrení cirkulujúcich nádorových buniek (CTC) v plnej krvi. Časť 3: Prípravky na analytické farbenie CTC |
| English title | 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 |
| Release Date: | 01. 04. 2020 |
| Date of withdrawal: | 01. 03. 2025 |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1027 |
| Level of incorporation: | idt CEN/TS 17390-3:2020 |
| Official Journal | 03/20 |
| Amendments | |
| Replaced by: | STN P CEN ISO/TS 7552-3:2025-03 (85 1027) |
| Repleces: | |
| Note in Official Journal: | Táto predbežná STN je určená na overenie. Pripomienky zasielajte ÚNMS SR najneskôr do januára 2022. |
| Subject of the standard: | This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) 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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