DIN Standards Committee Health Technologies
DIN CEN/TS 16945
; DIN SPEC 13228:2016-11
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma; German version CEN/TS 16945:2016
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Metabolomuntersuchungen in Urin, venösem Blutserum und -plasma; Deutsche Fassung CEN/TS 16945:2016
Procedure
VN
Overview
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.
Document: references other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory