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  • 1.  Storage conditions for MD

    Posted 21-Oct-2021 18:37
    Dear community

    I found a guide for pharma to help to determine the storage conditions/special storage conditions and related information that should be included in the label (Find the link below).

    https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-declaration-storage-conditions_en.pdf

    But I have not found anything similar for Medical Devices. Could you advise on where can I search o consult on this topic?

    Thanks!

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    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
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  • 2.  RE: Storage conditions for MD

    Posted 21-Oct-2021 22:08
    Hello!

    It will depend on things like the intended uses and the risks - medical devices vary a lot. But there are some standards.

    ISO 20417 is a basic for information to provide.
    ISO 15223-1 is a basic for symbols.
    ISO 780 isn't specific to medical devices, but has symbols especially for package handling in the distribution chain.
    IEC 60721-3 classifies different categories of indoor and outdoor storage and use environments.
    You can look at symbols on the ISO Online Browsing Platform: https://www.iso.org/obp/ui/#search
    Symbols 2620, 2621, and 0632 are commonly used.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Storage conditions for MD

    Posted 22-Oct-2021 05:55
    Hello Carolina,

    You may not find anything specific to medical devices in Europe, but there are some guidance documents and standards which talk about storage conditions and testing of these conditions.  There are standards like ASTM F1980 which talks about accelerated aging, there is the ICH Q1 guidance document, and there is some guidance out there concerning Good Distribution Practices (GDP) like for EU and Malaysia.  Some specific standards like WHO guidance, EU Pharmacopoeia, and USP have section on packaging and storage requirements like USP <659>.  You can also look at ASTM D4169 which talks about transport conditions.  There is an old FDA guidance from 1991 on shelf life of devices too.  You would be hard pressed to find just one standard or regulation about storage conditions, which need to kind of piece together from multiple sources.  Then as Anne provided there is information about how to present information such as storage and use conditions to the user and additional symbols which can be used.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Storage conditions for MD

    Posted 23-Oct-2021 15:21
    Dear Carolina, although seems to be very specific at first look, with sufficient patience the ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing contains very useful and generalisable thoughts and principles, how shelf-life, storage conditions and transportation should be validated. 

    regards

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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    Original Message


  • 5.  RE: Storage conditions for MD

    Posted 22-Oct-2021 09:00
    Hi Carolina,

    in addition to the points above (Risk management, intended purpose, etc. ), you may find guidance in the IEC 60601-1 series.
    >> It contains requirements about this environmental aspects which apply for many active devices.

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 6.  RE: Storage conditions for MD

    Posted 27-Oct-2021 17:32
    Hello,

    Thank you everyone for your answers and recommendations. They have been very useful. 



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    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


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