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CEN/TS 17305:2019:en

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA

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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 material or by mouth washes are not described in this technical specification. 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.


Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sidokset
Velvoittavat viittaukset
Tässä julkaisussa ei ole velvoittavia viittauksia
Vahvistuspäivä
12.04.2019
Julkaisupäivä
16.04.2019
Painos
1
Sivumäärä
18
Julkaisun kieli
englanti

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