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About This Item

 

Full Description

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).

.

 

Document History

  1. ISO 18113-1:2022

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

    • Most Recent
  2. ISO 18113-1:2009


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

    • Historical Version