prBAS EN ISO 18113-5:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Opšte informacije
Status:Projekt
Broj stranica:21
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 self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
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 professional use.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
EN ISO 18113-5:2024, identičan
ISO 18113-5:2022, identičan
Veza sa BAS standardima
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