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  • BSI
    BS EN ISO 20184-3:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated DNA
    Edition: 2021
    $435.35
    / user per year

Description of BS EN ISO 20184-3:2021 2021

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.



Standard NumberBS EN ISO 20184-3:2021
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated DNA
StatusDefinitive
Publication Date2021-06-01
ReplacesPD CEN/TS 16826-3:2018
Identical National Standard OfEN ISO 20184-3, ISO 20184-3
DescriptorsMedical technology, Medical specimens, Medical sciences, Medical inspection, DNA
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 12528 3
PublisherBSI
Pages24

The following editions for this book are also available...

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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