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 desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
-
Edición: 2
-
Comité Técnico :ISO/TC 210
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
PublicadoISO 15223-2:2010
-
Ahora