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Normas DIN – AENOR
DIN EN ISO 20166-3:2019-04

DIN EN ISO 20166-3:2019-04

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018); German version EN ISO 20166-3:2019

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 3: ADN extrait (ISO 20166-3:2018); Version allemande EN ISO 20166-3:2019

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)-Gewebeproben - Teil 3: Isolierte DNS (ISO 20166-3:2018); Deutsche Fassung EN ISO 20166-3:2019

Fecha:
2019-04 /Active
Equivalencias internacionales:

EN ISO 20166-3 (2019-01)

ISO 20166-3 (2018-12)

Relación con otras normas DIN:
Resumen:
This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities.DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status or even structural changes which can lead to e. g., spurious copy number changes in array-CGH profiles. These modifications of the DNA molecules can impact the validity and reliability of the examination test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA examination.
Keywords:
Biomedical, Definitions, Deoxyribonucleic acid, Diagnosis, DNA, In vitro, Insulated, Investigations, In-vitro diagnostic, Laboratories, Medical sciences, Medical technology, Methods of analysis, Molecular structure, Paraffin, Samples, Specification (approval), Specimens, Storage, Test materials, Tissue
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