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ISO 18113-1:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements
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ISO 18113-1:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements

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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).

.

SDO ISO: International Organization for Standardization
Document Number ISO 18113
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
Not Available ISO 18113-1:2022 Revision