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STN EN ISO 20184-3

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Electronic version (pdc file)

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Name: STN EN ISO 20184-3
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 postupov pred vyšetrením zmrazeného tkaniva. Časť 3: Izolované DNA (ISO 20184-3: 2021)
English title Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
Release Date: 01. 09. 2021
Date of withdrawal:
ICS: 11.100.10
Sorting character/National clasification code 85 6573
Level of incorporation: idt EN ISO 20184-3:2021, idt ISO 20184-3:2021
Official Journal 08/21
Amendments
Replaced by:
Repleces: STN P CEN/TS 16826-3:2019-01 (85 6573)
Note in Official Journal:
Subject of the standard: This document specifies requirements and 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 examinations 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)