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STN P CEN ISO/TS 7552-3

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Electronic version (pdc file)

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Name: STN P CEN ISO/TS 7552-3
Validity: Valid
Number of pages: 28
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 žilovej plnej krvi. Časť 3: Prípravky na analytické farbenie cirkulujúcich nádorových buniek (ISO/TS 7552-3: 2024)
English title 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)
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 7552-3:2024, idt ISO/TS 7552-3:2024
Official Journal 02/25
Amendments
Replaced by:
Repleces: STN P CEN/TS 17390-3:2020-04 (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, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an 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. Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2. NOTE 1 The requirements given in this document can also be applied to other ...
Preview: Náhľad normy (PDF)