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  • BSI
    BS EN ISO 4307:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
    Edition: 2021
    $313.97
    / user per year

Description of BS EN ISO 4307:2021 2021

This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human 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. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing materiasl or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Standard NumberBS EN ISO 4307:2021
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
StatusDefinitive
Publication Date2021-11-04
ReplacesPD CEN/TS 17305:2019
Identical National Standard OfEN ISO 4307, ISO 4307
DescriptorsTesting, Tests, Documentation, Human body, Humans, DNA
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 14124 5
PublisherBSI
Pages22

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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