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
Reference number
ISO 18113-3:2022
Edición 2
2022-10
International Standard
Vista previa
ISO 18113-3:2022
79868
No disponible en español
Publicado (Edición 2, 2022)

ISO 18113-3:2022

ISO 18113-3:2022
79868
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) 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

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

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)