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Standard ČSN EN ISO 20184-3 1.12.2021 preview

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ČSN EN ISO 20184-3 (857031)

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

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STANDARD published on 1.12.2021


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The information about the standard:

Designation standards: ČSN EN ISO 20184-3
Classification mark: 857031
Catalog number: 513190
Publication date standards: 1.12.2021
SKU: NS-1043025
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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In vitro diagnostic test systems

Annotation of standard text ČSN EN ISO 20184-3 (857031):

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 of the standard ČSN EN ISO 20184-3 (857031)

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