ISO 23118:2021

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

This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.