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  • 1.  Electrical safety and EMC testing standards for IVD's - USFDA

    This message was posted by a user wishing to remain anonymous
    Posted 16-Nov-2020 09:25
    This message was posted by a user wishing to remain anonymous

    Hello RA folks,

    I was looking at USFDA recognized consensus standards database for safety and EMC standards for IVD devices for example - Blood pressure monitoring systems and blood glucose measuring devices (battery operated).

    I was only able to locate IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements) in the FDA Recognised Consensus standards database.

    Can anyone provide insight on what standards and versions are accepted by FDA for Electrical safety and EMC testing of such products?

    Thanks!


  • 2.  RE: Electrical safety and EMC testing standards for IVD's - USFDA

    This message was posted by a user wishing to remain anonymous
    Posted 16-Nov-2020 16:56
    This message was posted by a user wishing to remain anonymous

    FDA just issued a new guidance today on EMC, so take a look.


  • 3.  RE: Electrical safety and EMC testing standards for IVD's - USFDA

    Posted 17-Nov-2020 01:52
    Just because FDA doesn't recognize a standard doesn't mean you can't submit a product using that standard.  There are a lot of standards that don't rely on recognized standards.  An example for IVD that you may be eluding to is

    IEC 61010-2-101:2018 

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.

    Recognized Standards are voluntary and not mandatory for submission to the FDA for any submission type.



    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 4.  RE: Electrical safety and EMC testing standards for IVD's - USFDA

    Posted 17-Nov-2020 02:43
    Hello Anon,

    The two standards for IVD instruments are: IEC 61010-1 for electrical safety and IEC 61326 for electromagnetic disturbance (electromagnetic compatibility).

    However, if devices you are describing as blood glucose meters, those used for diabetes monitoring, you may also need to consider other standards including IEC 60601-1 standard for medical devices, and other safety standards specific to home use devices, i.e. IEC 60601-1-11.  Blood glucose meters are considered IVDs, but also in that realm of medical devices since they are used by laypersons at home.  In addition blood pressure monitoring devices are not considered IVDs, but medical devices, so indeed they would need to conform with IEC 60601-1 (safety) and IEC 60601-1-2 (EMD/EMC).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 5.  RE: Electrical safety and EMC testing standards for IVD's - USFDA

    Posted 18-Nov-2020 09:33
    For IVD devices, FDA has been asking for EMC compliance to 60601-1-2 instead of 61326. In our case, FDA requested a gap analysis between the testing completed under 61326-1 and 61326-2-6 against the test levels required under 60601-1-2, testing to bridge that gap, and a risk analysis for what could go wrong with the device if exposed to higher levels of EMI/EMD including ESD than the demonstrated immunity under IEC 61326-1:2012 and 61326-2-6:2012 or a scientific rationale for not completing that testing.

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    Patricia Taige RAC
    Regulatory Affairs Manager
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  • 6.  RE: Electrical safety and EMC testing standards for IVD's - USFDA

    Posted 18-Nov-2020 12:31
    The Electromagnetic Compatibility (EMC) of Medical Devices Draft Guidance that just came out on 11/17/2020 from the FDA will definitely apply to IVDs.  In Section C of the Draft Guidance it states"Most in vitro diagnostic devices (IVDs) are outside the scope of 60601-1-2. In the absence of a recognized EMC standard for IVDs16 298 at the time of this guidance 299 publication, we recommend using the test methods in IEC 61326:2-6, using acceptance 300 criteria specific to the device's functions and intended use, and using the test levels 301 specified by 60601-1-2 for the device's intended use environment."  But there is a lot more to the Guidance than just that statement that an IVD will have to follow so read the whole Guidance.  Note you still have time to comment back to the FDA on the Guidance positive or negative about the Guidance 60 days from when published in the Federal Register which I think was either on the 17 or 16th of November.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------