Draft
International Standard
ISO/DIS 15223-2
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 2: Symbol development, selection and validation
Reference number
ISO/DIS 15223-2
Edition 2
© ISO 2026
Proyecto Norma internacional
En desarrollo
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
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.

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