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Use of the Hercules MCU in a life-critical medical equipment

jonathan vandamme
Prodigy 65 points
Other Parts Discussed in Thread: RM46L852

Hi,

My team is evaluating the possibility to use the Hercules microcontrollers in a life-critical medical device that we are designing. On the RM46's webpage, some of the suggested medical applications seem to be life-critical applications, such as robotic surgery, ventilators and defibrillators. However, when reading some doc about the RM46L852, we stumbled upon this note at the very end of the specsheet:

No TI components are authorized for use in FDA Class III (or similar life-critical medical equipment) unless authorized officers of the parties have executed a special agreement specifically governing such use.

What kind of agreement is this referring to ? Do we need a special permission from TI to use this product in our device ?

Thank you for your time.

Jonathan

  • 0
    TI__Guru**** 191486 points
    Hi Jonathan,
    We will have someone to get back with you on your question.
  • 0
    TI__Intellectual 1835 points

    Jonathan,

    Hercules MCUs do have many features which make them an excellent fit for medical applications.  As the datasheet does mention, TI’s standard terms and conditions of sale do require a special signed agreement before components are authorized for use in life-critical applications.  If you would like to discuss further, we will contact you by friend request to do this by email or you can go through you local TI sales or FAE contact as well.

    Best Regards,

    Roy Haley

  • 0 in reply to Roy Haley
    Prodigy 65 points

    Hi, 

    Thank you for your answer. Since we are evaluating many MCUs for our application, I would like to discuss further about this issue to determine if this could be an impediment to the certification process.

    Best regards,

    Jonathan