DS/EN ISO 23118
Molecular in vitro diagnostic examinations – Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
| Organization: | DS |
| Publication Date: | 7 June 2021 |
| Status: | active |
| Page Count: | 32 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
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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