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  • BSI
    PD CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue - Isolated DNA
    Edition: 2018
    $313.97
    / user per year

Description of PD CEN/TS 16826-3:2018 2018

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.

Standard NumberPD CEN/TS 16826-3:2018
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue - Isolated DNA
StatusWithdrawn
Publication Date2018-07-23
Withdrawn Date2021-06-01
Replaced ByBS EN ISO 20184-3:2021
Identical National Standard OfCEN/TS 16826-3:2018
DescriptorsMedical technology, Medical specimens, Medical sciences, Medical inspection, DNA
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 51738 9
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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