IEC 60601 certification for Cyton?

BioPotentialBioPotential
edited June 2019 in Cyton
What more would it take to get the Cyton to be 60601 compliant. I see that there is an EEG standard 60601-2-26, I don't know what other standards would be applicable.

The points that I wish to highlight is

1.
Input-referred noise :  within 6uV p-p
Cyton has the ADS1299 that is touted as 1uv p-p @ gain of 6, however that would be at a particular sample rate. Higher sample rates would have more noise, and obviously external components would have a further effect on that.

I'm not sure how the current noise values of the Cyton match up to the standards, do we have any noise values available?

2. Defibrillator protection
Cyton seems to have ESD protection at its inputs but I don't see any Defibrillator protection on the inputs. Especially considering 5KV @ 400Joules that the Cyton would be subjected to at the electrode inputs during the Defibrillation test?

Any inputs would be appreciated!

Comments

  • wjcroftwjcroft Mount Shasta, CA
    edited June 2019
    Did you try looking at some of these previous threads?


    IEC 60601 certification costs tens of thousands of dollars. And is generally done by established medical device companies with packaged systems. OpenBCI is NOT a packaged device, it just consists of bare boards. With all signal traces exposed. Hence could never be certified in this 'Maker' / builder / experimenter format.

    The reason medical device companies can afford certification, is that they generally charge many thousands of dollars per device. 

    Regards,

    William

  • BioPotentialBioPotential
    Is there any problem of having an open board for devices like EKG's, ECG's can't it be certified as a module?
    BTW I just needed info on the topics I listed above, I'm aware of the cost's involved. And needed to know, how much work would be involved in getting the Cyton compliant to standards, from a design point of view.

  • wjcroftwjcroft Mount Shasta, CA
    "From a design point of view" there are MANY fail safe features required in IEC 60601 devices. Such that if particular components short out or fail, the system is guaranteed to be safe to the patient. These are all documented in the IEC standards documents. It's quite extensive.


    When medical device companies pay compliance testing companies thousands of dollars, this is what they are looking for and identifying in the design, so that it can be brought into compliance with the standard. OpenBCI boards were not designed with this in mind.

    These standards are very very complex,


    I may be mistaken, but bare circuit board I don't believe could ever be certified. As the enclosure itself requires considerable fail safe protections.

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