BAS EN ISO 18113-3:2025
In vitro dijagnostička medicinska sredstva - Informacije proizvođača (označavanje) – Dio 3: In vitro dijagnostički instrumenti za profesionalnu primjenu
Opće informacije
Status: Važeći
Broj strana: 18
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 18.06.2025
Tehnički komitet:
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Apstrakt
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 18113-3:2024, identičan
- ISO 18113-3:2022, identičan