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Norm
ISO 18113-1:2022
Ausgabedatum: 2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 53 Seiten
Sprache:
Englisch
ICS
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).
.
ISO 18113-1:2022
2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1:...
Norm
↖
ISO 18113-1:2009
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1:...
Norm
