ČSN P CEN/TS 16826-3 (857031)

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

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STANDARD published on 1.2.2019


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The information about the standard:

Designation standards: ČSN P CEN/TS 16826-3
Classification mark: 857031
Catalog number: 506164
Publication date standards: 1.2.2019
SKU: NS-935678
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

In vitro diagnostic test systems

Annotation of standard text ČSN P CEN/TS 16826-3 (857031):

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

These changes apply to this standard:

ČSN P CEN/TS 16826-3:2019/Z1 (857031) Change

Molekulární diagnostická vyšetření in vitro - Specifikace předvyšetřovacích postupů pro čerstvě zmraženou tkáň - Část 3: Izolovaná DNA (Norma k přímému použití jako ČSN).

Change published on 1.12.2021

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