Reference number
ISO 18113-4:2022
© ISO 2025
International Standard
ISO 18113-4:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
Edition 2
2022-10
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Published (Edition 2, 2022)

ISO 18113-4:2022

Language
Format
CHF 65
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Abstract

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.

This document can also be applicable to accessories.

This document is applicable to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

a) IVD instruments or equipment;

b) IVD reagents for professional use.

General information

  • Status
     : Published
    Publication date
     : 2022-10
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 11
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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