ISO 18113-1:2022
ISO 18113-1:2022



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 

  •  :  Published
     : 2022-10
  •  : 2
     : 53
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    11.100.10 In vitro diagnostic test systems

Buy this standard

Format Language
std 1 187 PDF + ePub
std 2 187 Paper
  • CHF187

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