Resumen
Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1.
The purpose of Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 is to ensure that symbols included in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-1 are readily understood by the target group.
If the symbol validation process detailed in Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010 has been complied with, then the residual risks, as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 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.
Ïã¸ÛÁùºÏ²Ê¿ª½± 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: En desarrolloEtapa: Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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·¡»å¾±³¦¾±Ã³²Ô: 2
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°ä´Ç³¾¾±³Ùé Técnico :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210
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