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
Edición 2
2022-10
© ISO 2024
International Standard
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Publicado (Edición 2, 2022)

ISO 18113-4:2022

Formato
Idioma
CHF 63
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Resumen

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.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2022-10
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 11
  • Comité Técnico :
    ISO/TC 212
    ICS :
    11.100.10 
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