ISO 18113-5:2009Withdrawn

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — Partie 5: Instruments de diagnostic in vitro pour auto-tests

This edition has been replaced by ISO 18113-5:2022.

Abstract / scope

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.

ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

ISO 18113-5:2009 can also be applied to accessories.

Life cycle

Replaced by

ISO 18113-5:2022PublishedIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testingInternational Standard · Published 6 Oct 2022 · ISO/TC 212