PD CEN/TS 17305:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA

PD CEN/TS 17305:2019

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

Status : Current   Published : April 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

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.




Standard NumberPD CEN/TS 17305:2019
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
StatusCurrent
Publication Date15 April 2019
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15190
Informative References(Provided for Information)EN ISO 9000:2015, EN ISO 22174:2005, EN ISO 20184-1:2018, EN ISO 18113-1:2011, EN ISO 11139:2018, EN ISO 17511:2003, EN ISO/IEC 17020
International RelationshipsCEN/TS 17305:2019
DescriptorsTests, Documentation, Storage, Humans, DNA
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour la salive - ADN humain extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für Speichel. Isolierte menschliche DNA
CommitteeCH/212
ISBN978 0 539 01384 9
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size718 KB
Price£130.00


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