Verkkokauppa
CEN/TS 17305:2019:en Kumottu
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
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.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
ISO 15190:2003 Medical laboratories -- Requirements for safety
ISO 15190:2003 Medical laboratories -- Requirements for safety
Tekninen komitea
Vahvistuspäivä
12.04.2019
Kumouspäivä
19.11.2021
Painos
1
Sivumäärä
18
Julkaisun kieli
englanti