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DS90UB935-Q1: DS90UB* family medical certification

Part Number: DS90UB935-Q1

Hi there,

we're thinking about using Serializers and Deserializers from the DS90UB9* family for surgical robot. Do you have any information for me whether the DS90UB would withstand a medical certification process? I saw it's certified for automotive applications so that's a good start but how about medical? 

For the Serializer side we currently focus on the DS90UB935-Q1 on the deserializer side we're not sure yet as the receiving interface is not defined yet.

Thanks,

Lennart

  • Hello Lennart,

    Do you have any information on which specific test standards or qualifications are needed? We can help find the information for you. 

    Best Regards,

    Casey 

  • Hi Casey,

    so far I only know of IEC 60601-1 but I doubt that will be the end of it. However, I think we can start from there.

    Thanks for your quick answer!

    Lennart

  • Hi Lennart,

    It seems what we found in terms of  IEC 60601-1 is that it's intended for system level testing like end equipment. I can't seem to find a specification/test for semiconductor parts, do you know if there is a spec or certification that would apply to us which falls under Medical?

    Regards,

    Mandeep Singh

  • From IEC 60601-1

     

    “This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.”

     

    Compared to how AEC-Q100 defines its scope in section 1 of AEC-Q100 – REV-H:

     

    “This document contains a set of failure mechanism based stress tests and defines the minimum stress test driven qualification requirements and references test conditions for qualification of integrated circuits (ICs). These tests are capable of stimulating and precipitating semiconductor device and package failures.”

  • Hi Lennart,

    Do you have any further questions regarding this topic?

    Regards,

    Mandeep Singh

  • Hi Mandeep,

    unfortunately the relevant project made a step back and got a lot more basic, but I'm very positive that this subject will pop up later again. If you want I create a new Thread once that happens.

    Regards,

    Lennart

  • Hi Lennart,

    No worries, I'll close this thread. Please open a new one and you can reference this one if needed.

    Regards,

    Mandeep Singh