ISO 15223-2:2010 Preview

Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

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.


General information

  • Current status : Published
    Publication date : 2010-01
  • Edition : 1
    Number of pages : 16
  • :
    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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