International Standard
ISO 18113-1:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
Reference number
ISO 18113-1:2022
Edition 2
2022-10
© ISO 2024
International Standard
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Published (Edition 2, 2022)

ISO 18113-1:2022

Format
Language
CHF 194
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Abstract

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).

.

General information

  • Status
     : Published
    Publication date
     : 2022-10
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 53
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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