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
International Standard
Vista previa
ISO 18113-4:2022
79869
No disponible en español
Publicado (Edición 2, 2022)

ISO 18113-4:2022

ISO 18113-4:2022
79869
Idioma
Formato
CHF 63
Convertir Franco suizo (CHF) a tu moneda

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

  •  : Publicado
     : 2022-10
    : Norma Internacional publicada [60.60]
  •  : 2
     : 11
  • ISO/TC 212
    11.100.10 
  • RSS actualizaciones

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