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ISO 18113-1:2009Withdrawn

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — Partie 1: Termes, définitions et exigences générales

This edition has been replaced by ISO 18113-1:2022.

Abstract / scope

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

Life cycle

Replaced by

ISO 18113-1:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirementsInternational Standard · Published 6 Oct 2022 · ISO/TC 212