ISO 18113-1:2022
p
ISO 18113-1:2022
79866

Abstract

 Preview

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

en
Format Language
std 1 178 PDF + ePub
std 2 178 Paper
  • CHF178

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.