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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.


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2010-01
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    01.080.20 Graphical symbols for use on specific equipment
    11.040.01 Medical equipment in general

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  3. Каталог стандартов
  4. МКС
  5. 01
  6. 01.080
  7. 01.080.20
  8. ISO 15223-2:2010