prBAS EN ISO 18113-1:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements
Opšte informacije
Status:Projekt
Broj stranica:63
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 defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
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Životni ciklus
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Izvorni dokument i stepen usklađenosti
EN ISO 18113-1:2024, identičan
ISO 18113-1:2022, identičan
Veza sa BAS standardima
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