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  • 1.  IVD Instruments and UL Symbol

    This message was posted by a user wishing to remain anonymous
    Posted 23-Aug-2022 08:59
    This message was posted by a user wishing to remain anonymous

    If an IVD instrument has successfully passed applicable UL testing, is it required to have the UL symbol on the instrument/label?


  • 2.  RE: IVD Instruments and UL Symbol

    Posted 23-Aug-2022 12:22
    No, it's not required.
    However, your customers might have concerns if they don't see evidence of electrical safety verification.

    https://marks.ul.com/about/

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    Anne LeBlanc
    United States
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  • 3.  RE: IVD Instruments and UL Symbol

    Posted 24-Aug-2022 04:19
    Support Anne's statement is not required, but generally (especially in the US) it is better to have it on the labelling.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: IVD Instruments and UL Symbol

    Posted 24-Aug-2022 09:35
    "Successfully passes applicable UL testing" is a broad term and could mean a few different things. UL (and all of the other NRTLs) offer different levels of certification. You would first need to ensure you contracted them for their NRTL service which allows you to apply their NRTL mark on your product. This will require 2-4, unannounced, follow-up inspections per year and associated annual fees to ensure the product they tested has not been changed in a way which would required re-testing.

    Another important note, any NRTL can test to the applicable UL standards as long as they are accredited to said standard. I don't want to assume you had UL test your product because there are a number of other labs which offer the same testing. You might actually need to apply a MET, ETL, Nemko mark, etc.

    Aside from those points I agree with what others have said but I encourage you to look at the applicable law straight from OSHA:
    https://www.osha.gov/nationally-recognized-testing-laboratory-program/frequently-asked-questions

    What requirements does OSHA have regarding NRTLs?

    "OSHA's standards contain requirements for approval (i.e., testing and certification) of certain products by a Nationally Recognized Testing Laboratory (NRTL). For example, in 29 CFR 1910.303, OSHA requires NRTL approval for many kinds of electrical equipment when they are used in the workplace. Standards like these help protect workers by ensuring products and equipment are designed for safe use in the workplace."

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    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Website: www.biotexmedical.com
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