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
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Estado: PublicadoFecha de publicación: 2010-01Etapa: Norma Internacional para revisar [90.92]
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Edición: 1Número de páginas: 16
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Comité Técnico :ISO/TC 210
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Ciclo de vida
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Anteriormente
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Ahora
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Será reemplazada por
En desarrolloISO/AWI 15223-2