Molekulární diagnostická vyšetření in vitro - Specifikace předvyšetřovacích postupů pro formalinem fixovanou a parafínem archivovanou (FFPE) tkáň - Část 3: Izolovaná DNA (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.7.2019
Designation standards: ČSN EN ISO 20166-3
Classification mark: 857032
Catalog number: 507449
Publication date standards: 1.7.2019
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
This document gives guidelines on 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 document 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, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. NOTE: International, national or regional regulations or requirements can also apply to specific topics covered in this document