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ADS1294: IEC60601-1, IEC60601-2-27 and IEC60601-2-51 compliance?

Gregory Duperon
Expert 6050 points
Part Number: ADS1294

I have a customer currently using ADS1294 in a product undergoing 60601-1 certification.

The certifier is concerned about about the damage/degredation of performance the chip could sustain the normal aging process. The failure modes considered are:

 

-short between any 2 pins (e.g. Vcc to IN1+) must not result in a total patient current over 10uA on the patient.
 -short between any 4 pins (e.g. Vcc to IN1+ & GND to IN1-) must not result in a total patient current over 50uA on the patient.

 

These test cases are aggressive but can be relaxed if it can be proved that such failures are not expected to happen for the life of the product (5 years). Do we have test reports/documentation supporting the claim that ADS1294 is IEC60601-1, IEC60601-2-27 and IEC60601-2-51 compliant? Also, do we have a pareto of fail modes over time and their occurrences?

 

In addition, has any company certified a medical product using the ADS1294? With what package (ZXG, PAG)?

  • 0
    TI__Guru**** 168605 points
    Hi Gregory,

    The ADS1294 does not claim to be compliant to the various IEC60601 standards. Patient protection is part of a system level design, and we certainly do support systems needing to meet the various IEC60601 standards. We'd be happy to discuss this further with you off line and point you to life test details/results for the ADS1294.