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  • 1.  SaMD - Symbols for Labelling vs Icons

    This message was posted by a user wishing to remain anonymous
    Posted 17-Nov-2022 09:35
    This message was posted by a user wishing to remain anonymous

    Hi,

    I have a question about where to draw the line between symbols and icons used within SaMD (web based). 

    The symbols for ISO 15223-1 are used in the SaMD; however, we do use other icons to indicate errors and informative notes within the software. Would these be considered custom symbols and therefore need validating per ISO 15223-2?

    Where do we draw the line between what is a symbol and what is an icon? This way, we can reduce the control we need to have on icons from a labelling perspective.

    Thanks!


  • 2.  RE: SaMD - Symbols for Labelling vs Icons

    Posted 18-Nov-2022 03:00
    Anon,

    I think you might find some regulatory reviewers unfortunately would not draw a clear distinction between symbols and icons which may be used within a Software as a Medical Device (SaMD).  Indeed the symbols from ISO 15233-1 are quite clear or identified in the standard.  If the product uses specific icons to indicate errors or other informative notes for the user, at a minimum there would be a glossary of these icons (symbols) in your Instructions for Use (IFU).  This then leads into other areas such as Usability and Risk where the icon should be assessed from a user perspective if readily understood or if there should be additional indicators or notes when an icon might not be recognisable.  Much of this depends on the SaMD, how it is used, what it is used for, and definitely the type of icons used.  Where do you draw the line?  You draw the line.  Meaning, within your own internal technical documentation, you identify what are symbols and what are icons.  However, I would use caution on reducing control of icons, because from a usability and risk perspective (depending on the device) a regulatory reviewer again might not make a demarcation between the two.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: SaMD - Symbols for Labelling vs Icons

    Posted 18-Nov-2022 17:39
    To add on Richard's comment:
    In my previous work experience with SaMD, we follow ISO15223-1 for common used symbols. For other specific custom defined icons, you need to test it with your intended users in the usability engineering test, esp if the web-based interface is for lay person use. 

    Best regards

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    May Meng, PhD, RAC
    Senior Consultant
    Oxford
    United Kingdom
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    Original Message


  • 4.  RE: SaMD - Symbols for Labelling vs Icons

    Posted 19-Nov-2022 12:10
    To some extent it is possible to distinguish between symbols, icons, pictograms, and graphics.
    Ref: https://www.fda.gov/medical-devices/device-labeling/use-symbols-labeling-frequently-asked-questions

    But it's not always clear where the lines can be drawn between them, and all of them could contribute to usability and risk.

    There's some art involved in deciding which need specific validations and which can be validated simply as part of the whole.

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    Anne LeBlanc
    United States
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    Original Message


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