ISO/AWI 15223-2
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Reference number
ISO/AWI 15223-2
Edición 2
© ISO 2024
Working draft
En desarrollo
Un grupo de trabajo ha preparado un borrador.
Reemplazará ISO 15223-2:2010

Resumen

ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Informaciones generales

  • Estado
     : En desarrollo
    Etapa
    : Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
  • Edición
     : 2
  • Comité Técnico :
    ISO/TC 210
  • RSS actualizaciones

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