prBAS EN ISO 18113-3:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
Opšte informacije
Status:Projekt
Broj stranica:20
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:3.
Datum realizacije:22.10.2024
Predviđeni datum naredne faze:12.03.2025
Tehnički komitet:BAS/TC 25, Zaštita zdravlja
Direktive:
2017/746, Uredba (EU) o medicinskim sredstvim u in vitro dijagnostici
ICS:
11.100.10, In vitro dijagnostički test sistemi
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
Veza sa BAS standardima
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