BAS EN ISO 18113-1:2025
In vitro dijagnostička medicinska sredstva - Informacije proizvođača (označavanje) – Dio 1: Termini, definicije i opći zahtjevi
Opće informacije
Status: Važeći
Broj strana: 59
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 18.06.2025
Tehnički komitet:
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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