STN P CEN ISO/TS 7552-1
| Name: | STN P CEN ISO/TS 7552-1 |
| Validity: | Valid |
| Number of pages: | 32 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Molekulárno-diagnostické vyšetrenia in vitro. Špecifikácie predbežných vyšetrení cirkulujúcich nádorových buniek (CTC) v žilovej plnej krvi. Časť 1: Izolovaná RNA (ISO/TS 7552-1: 2024) |
| English title | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024) |
| Release Date: | 01. 03. 2025 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1027 |
| Level of incorporation: | idt CEN ISO/TS 7552-1:2024, idt ISO/TS 7552-1:2024 |
| Official Journal | 02/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN P CEN/TS 17390-1:2020-04 (85 1027) |
| Note in Official Journal: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do novembra 2026 Úradu pre normalizáciu, metrológiu a skúšobníctvo. |
| Subject of the standard: | This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment and isolation, RNA isolation and storage, and documentation of venous whole blood specimens intended for the examination of RNA isolated from 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 the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-1. This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom. This document does not cover ... |
| Preview: | Náhľad normy (PDF) |