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
Reference number
ISO 18113-4:2022
Edition 2
2022-10
International Standard
Read sample
ISO 18113-4:2022
79869
Published (Edition 2, 2022)

ISO 18113-4:2022

ISO 18113-4:2022
79869
Language
Format
CHF 63
Convert Swiss francs (CHF) to your currency

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

  •  : Published
     : 2022-10
    : International Standard published [60.60]
  •  : 2
     : 11
  • ISO/TC 212
    11.100.10 
  • RSS updates

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