Regulatory Open Forum

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  • 1.  Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2019 09:22
    This message was posted by a user wishing to remain anonymous

    My understanding is the Symbols such as Lot number, expiration date are free for use. 

    But someone told me we have to purchase symbols then we can put on label.

    I am confused, can anyone please help? thanks!


  • 2.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 12-Jul-2019 10:04
    Refer to the ISO customer license agreement:
    https://www.iso.org/terms-conditions-licence-agreement.html​

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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  • 3.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 15-Jul-2019 02:50
    Someone posted this in another thread.  Personally I would find it hard to believe a company would have to pay ISO to use symbols, though to be honest it does not surprise me in the least (standards should be free ! get my jib in there).  I do not know the copyright or legal requirements around the symbol use, but maybe it is just having ISO 15223-1 standard owned by the company allows use of the symbol.  (Anne that link is broken.)

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 16-Jul-2019 04:04
    According to the ISO website (e.g. https://www.iso.org/obp/ui/#iso:grs:7000:2608), you can pay CHF 30 to buy the original artwork for each symbol in three different formats, but there is no indication that you are purchasing a licence to use a copyrighted symbol.

    Most companies just copy the symbols that they need from the ISO 15223-1 standard, and while I see nothing in the standard that states that you can use them for free, neither is there anyting that says that each symbol is copyrighted, and that you therefore have to purchase a licence to be able to use it.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
    www.donawa.com
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  • 5.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 16-Jul-2019 09:25
    Here's another version of the link: https://www.iso.org/terms-conditions-licence-agreement.html#Customer-Licence

    And here's the text: "You may use codes (such as language, currency, and country) and graphical symbols for the implementation of their respective ISO standard(s). For example, this means using the symbol in accordance with its meaning as a graphical symbol, e.g., the "No smoking" symbol to designate a non-smokers' area. However, you may not post or resell these on the Internet. If you would like to use the codes or symbols differently, please contact us or your ISO member."

    It is written a little ambiguously. It sounds like putting the symbol on your device & labeling is fair use. I suppose it's possible they were trying to say it's only fair use after you've subscribed to their symbols collection, but the symbols collection is described elsewhere as a convenient one-stop location for all the standards' symbols.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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  • 6.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jul-2019 12:50
    This message was posted by a user wishing to remain anonymous

    Thank all you!


  • 7.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 17-Jul-2019 11:11
    I had this same question before and as Anne mentioned, the license agreement is definitely written ambiguously and left me confused about what to do.  I reached out to ISO and asked them how to legally use these symbols in our labeling.  Their response was that you can reproduce them after purchasing the standard, or buy them individually through their search function:  https://www.iso.org/obp/ui/#search/grs/15223

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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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  • 8.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jul-2019 12:35
    This message was posted by a user wishing to remain anonymous

    Hi, brittney,

    thanks for for sharing info! But what exactly does that mean?  Especially "reproduce"?  Do you have to purchase symbols in order to put on your label? 

    Thanks!


  • 9.  RE: Urgent: do you have to purchase ISO15223 Symbol for putting on label?

    Posted 17-Jul-2019 15:06
    Edited by Brittany Gibson 17-Jul-2019 15:06
    The way I interpreted it to mean was I either had to:
    a) purchase a copy of ISO 15223 and copy the symbols out of the standard to use (reproduce); or
    b) purchase them individually for use

    Either way there was a purchase involved - we chose to purchase the 15223 standard to avoid multiple single purchases of symbols.

    I hope this helps you!

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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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