ISO 15223-2:2010
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ISO 15223-2:2010
42343
недоступно на русском языке

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 

  •  :  Published
     : 2010-01
  •  : 1
  •  : ISO/TC 210 Quality management and corresponding general aspects for medical devices
  •  :
    01.080.20 Graphical symbols for use on specific equipment
    11.040.01 Medical equipment in general

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std 1 88 PDF
std 2 88 Бумажный
  • CHF88

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