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

ISO-18113-1 - 2ND EDITION - CURRENT
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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).

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Document Number

ISO 18113-1:2022

Revision Level

2ND EDITION

Status

Current

Publication Date

Oct. 1, 2022

Committee Number

ISO/TC 212