Reference number
ISO 18113-3:2022
© ISO 2024
International Standard
ISO 18113-3:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
Edition 2
2022-10
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Publicado (Edición 2, 2022)

ISO 18113-3:2022

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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 professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

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 self-testing.

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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  6. 11.100
  7. 11.100.10
  8. ISO 18113-3:2022