STN P CEN/TS 17390-1
| Name: | STN P CEN/TS 17390-1 |
| Validity: | Valid |
| Number of pages: | 25 |
| 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 1: Izolovaná RNA |
| English title | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA |
| Release Date: | 01. 04. 2020 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1027 |
| Level of incorporation: | idt CEN/TS 17390-1:2020 |
| Official Journal | 03/20 |
| Amendments | |
| Replaced by: | |
| 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 specimens intended for the examination of human cellular RNA isolated from Circulating Tumor 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. |
| Preview: | Náhľad normy (PDF) |