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  • 1.  ISO 15223 Question

    Posted 17-Feb-2022 09:22
    Edited by Ed Panek 17-Feb-2022 10:21

    "These symbols can be used on the medical device itself, on its packaging or in the accompanying information"

    The use of the word "can" and the word "or" this has created an interpretation question for us. Does this statement from the standard mean we must use these symbols in one of the three locations referenced? All of them? None of them?

    Also,
    Does the Model Number Symbol from the ISO 15223 standard have to be used every place the model number is printed on the device, packaging, and the instructions for use?

    Where should the Medical Device Symbol from the ISO 15223 standard be placed? Is just on the outer packaging enough?

    Does the Country of Manufacture Symbol from the ISO 15223 standard have to be used every place the country of manufacture is printed on the device, packaging, and the instructions for use?



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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 2.  RE: ISO 15223 Question

    Posted 17-Feb-2022 09:31

     

     

    Hi Ed,

     

    As you might expect, the ISO processes are quite particular about some term usage.  Some of this has to do with subtleties of meaning when terms are translated into other languages.

     

    Per the directive, "can" is used to indicate possibility, and does not denote a requirement.  The applicable section is...

     

     

    As I understand it from WG discussions regarding proposed use of and/or type constructions, "or" can actually mean both "and" and "or" – but I could be wrong on this point.  I suppose the directive may speak to this as well, but I haven't looked for it.

     

    Best regards,

     

    Ted

     

     

     

     




    Original Message


  • 3.  RE: ISO 15223 Question

    Posted 18-Feb-2022 08:23
    Hello Ed,

    I have been in many, many long discussions concerning a single word.  Ted is right that ISO does have definitions for the words such as must, can, should, etc. which is defined for how requirements may be applied.  Now the issue comes when different interpretations are made by auditors and reviewers - which are not consistent !  My application of symbols is apply what is required on the direct device label (primary packaging), then the secondary packaging like carton boxes maybe not all symbols are required or needed, and so forth.  The Instructions for Use (IFU) may have some symbols as well, but these are usually not the same as the labels.  Though recommend having a symbol glossary in the IFU which has any and all symbols used.  Accompanying information for me also means documents like quick reference guides, notification flyers, but it does not include marketing material such as brochures.  Though there are some who have different opinions.  I always go by common sense, but unfortunately some do not use this nice, novel concept.

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


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