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ADS1298 conformance to IEC60601

Timothy Starr
Expert 2445 points
Other Parts Discussed in Thread: ADS1298

Hello-

Does the ADS1298 confrom to IEC60601-2-25 and/or 60601-2-27? In patricular the pace detection circuit...

Thanks, and Best Regards,

-Tim Starr

  • 0
    TI__Guru**** 181021 points

    Hi Tim,

    The ADS1298 is a component which could be used in medical equipment.  As I understand the IEC60601-2-25, this is a listing of requirements for the actual end equipment, not the individual components within that equipment and/or system.  Pace detection could be done in software and/or hardware, but again - on the component level only, so there would be no applicable IEC or medical 'standard' to conform to in this case.

  • 0 in reply to Tom Hendrick
    Prodigy 50 points
    Hi Tom,

    I am doing an update of a product that has the ADS1298 (IPAG) designed into it, the product needs to be IEC60601-2-25 compliant. Would T.I. be able to provide an application note or a way in which we could set up this chip to ensure that it will be compliant? The unit has cables from the end equipment that directly connect to the chip. We would like to continue using this chip but we need to insure its compliance.

    Thank you and Best Regards,

    Dave
  • 0 in reply to Dave G
    TI__Guru 66446 points

    Hi Dave - Welcome to our forum!

    As Tom mentioned, the ADS1298 chip alone will not make your system IEC-compliant. The datasheet mentions these standards because the device features and performances enables you to design an IEC-compliant system. A couple of the requirements involve guaranteeing patient safety and minimum signal resolution, which is achieved by the whole system, not just the ADS1298.

    Unfortunately, IEC standards have to be purchased by the customer who is designing and certifying their system and TI does not have any documentation to provide additional guidance.

    Best Regards,

  • 0 in reply to Ryan Andrews
    Prodigy 50 points

    Hi Ryan,

    Thank you for getting back to me, that clarifies things a little better.  I understand that the whole system needs to comply to the standard and that the ADS1298 alone will not make the system complaint.  All of the other components state that they have been tested and met the standard.  I was more wondering if by adding the ADS1298 to the system will it still pass the standard's tests.  Which i believe you have answered this question "device features and performances enables you to design an IEC-compliant system."   the data sheet did not specifically state that it the chip met IEC60601-2-25 that's way i was asking. I do have a copy of the standard and if i understand you correctly as long as i adhere to it in my design, the ADS1298 will be able to pass the tests? (granted that everything else is also up to standard) 


    Thank you again for the response,

    Dave G.

  • 0 in reply to Dave G
    TI__Guru 66446 points
    Hi Dave - yes, you are correct. Glad to help. :)