CEN standards: Molecular in vitro diagnostic examinations and specifications for pre-examination processes for human specimen

Isolated microbiome DNA (CEN/TS 17626:2021) #

This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation. The CEN/TS are applicable to molecular in vitro diagnostic examinations performed by medical laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.

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Updated on 19 August, 2026