ISO 23118:2021 PDF

Scope: 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.

ISO 23118:2021 Referenced Document

ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
ISO 15190 Medical laboratories — Requirements for safety

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