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EVS-EN ISO 23118:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)

General information
Valid from 15.06.2021
Base Documents
ISO 23118:2021; EN ISO 23118:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.06.2021
Main
01.06.2016
Main
This document covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. The document 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. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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