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  • BSI
    21/30421396 DC BS EN ISO 4307. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
    Edition: 2021
    $44.66
    / user per year

Description of 21/30421396 DC 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 organizations performing biomedical research, and regulatory authorities.

Dedicated measures that need to be taken for saliva collected on absorbing material 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 Number21/30421396 DC
TitleBS EN ISO 4307. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
StatusDefinitive
Publication Date2021-02-18
Identical National Standard OfISO/DIS 4307
DescriptorsTesting, Tests, Documentation, Human body, Humans, DNA
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
PublisherBSI
Pages19

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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