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)

Publication date:   Oct 14, 2021

General information

60.60 Standard published   Jun 2, 2021

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
CEN/TS 16945:2016

NOW

PUBLISHED
EN ISO 23118:2021
60.60 Standard published
Jun 2, 2021