Resumen
ϲʿ 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ϲʿ 15223-1.
The purpose of ϲʿ 15223-2:2010 is to ensure that symbols included in ϲʿ 15223-1 are readily understood by the target group.
If the symbol validation process detailed in ϲʿ 15223-2:2010 has been complied with, then the residual risks, as defined in ϲʿ 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.
ϲʿ 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
Ciclo de vida
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Será reemplazada por
En desarrolloϲʿ/AWI 15223-2
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