PD CEN/TS 16945:2016 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma

PD CEN/TS 16945:2016

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma

Status : Superseded, Withdrawn   Published : May 2016 Replaced By : BS EN ISO 23118:2021

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This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.




Standard NumberPD CEN/TS 16945:2016
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
StatusSuperseded, Withdrawn
Publication Date31 May 2016
Withdrawn Date07 June 2021
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15189:2012, ISO 15190
Informative References(Provided for Information)ISO Guide 30:1992, ISO/TS 80004-6:2013
Replaced ByBS EN ISO 23118:2021
International RelationshipsCEN/TS 16945:2016
DescriptorsLaboratory testing, Quality assurance, Laboratories, Quality assurance systems, Medical laboratory equipment, Medical sciences, Quality, Deoxyribonucleic acid, Blood plasma, Laboratory accreditation, Medical technology, Quality management, Cells (biology), Management
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour l'analyse du métabolome dans l'urine et le sang veineux (sérum et plasma)
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für Metabolomuntersuchungen in Urin, venöses Blutserum und -plasma
CommitteeCH/212
ISBN978 0 580 93674 6
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size1.933 MB
Price£134.00


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