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ČSN EN ISO 20166-3 (857032)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
Translate name
STANDARD published on 1.7.2019
The information about the standard:
Designation standards: ČSN EN ISO 20166-3
Classification mark: 857032
Catalog number: 507449
Publication date standards: 1.7.2019
SKU: NS-953063
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 20166-3 (857032):
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
Preview of the standard ČSN EN ISO 20166-3 (857032)
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