Tema de trabajo aprobado
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 15223-2
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 15223-2
Edition 2
Tema de trabajo aprobado
Ïã¸ÛÁùºÏ²Ê¿ª½±/AWI 15223-2
85544
Un grupo de trabajo ha preparado un borrador.
¸é±ð±ð³¾±è±ô²¹³ú²¹°ùá Ïã¸ÛÁùºÏ²Ê¿ª½± 15223-2:2010

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

  •  : En desarrollo
    : Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
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  • Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210
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