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CEN/TS 16945:2016

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

Publication date:   Jul 18, 2016

General information

99.60 Withdrawal effective   Jun 2, 2021

CEN

CEN/TC 140 In vitro diagnostic medical devices

Technical Specification

11.100.10   In vitro diagnostic test systems

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Scope

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.

Life cycle

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WITHDRAWN
CEN/TS 16945:2016
99.60 Withdrawal effective
Jun 2, 2021

REVISED BY

PUBLISHED
EN ISO 23118:2021