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.
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).
This document is available in electronic format only.
Date of Publication: October 1, 2022
Order Code PDF: ISO181131Ed2E
Order Code Print: print not available
ISO 18113-1:2022 Additional Details
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.