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CEN/TS 16826-3:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

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Kehtetu alates 15.06.2021
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CEN/TS 16826-3:2018
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puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.06.2021
Põhitekst
01.08.2018
Põhitekst
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.
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EVS-EN ISO 20166-3:2019

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CEN/TS 17305:2019

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
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CEN/TS 17390-1:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
Uusim versioon Kehtiv alates 03.02.2020
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CEN/TS 17390-3:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
Uusim versioon Kehtiv alates 03.02.2020