ISO 18113-1:2022
International Standard
Current Edition
·
Approved on
06 October 2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
ISO 18113-1:2022 Files
English
53 Pages
Current Edition
BHD
96.04
ISO 18113-1:2022 Scope
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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