Reference number
ISO 18113-5:2022
© ISO 2024
International Standard
ISO 18113-5:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Edition 2
2022-10
Preview
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Publicado (Edición 2, 2022)

ISO 18113-5:2022

Idioma
Formato
CHF 63
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Resumen

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.

This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.

This document can also be applicable to accessories.

This document does not apply to:

a) instructions for instrument servicing or repair;

b) IVD reagents, including calibrators and control materials for use in control of the reagent;

c) IVD instruments for professional use.

Informaciones generales

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