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STN P CEN/TS 16826-3

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Electronic version (pdc file)

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Name: STN P CEN/TS 16826-3
Validity: Withdrawn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 zmrazených tkanív. Časť 3: Izolovaná DNA
English title Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
Release Date: 01. 01. 2019
Date of withdrawal: 31. 05. 2024
ICS: 11.100.10
Sorting character/National clasification code 85 6573
Level of incorporation: idt CEN/TS 16826-3:2018
Official Journal 12/18
Amendments
Replaced by: STN EN ISO 20184-3:2021-09 (85 6573)
Repleces:
Note in Official Journal: Táto predbežná STN je určená na overenie. Pripomienky zasielajte ÚNMS SR najneskôr do júla 2021.
Subject of the standard: This document gives recommendations for the handling, storage, processing and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Preview: Náhľad normy (PDF)