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Original question:

TS5A3159: Is the product suitable for Class 2 medical devices?

SN74LV1T02: Is the product suitable for Class 2 medical devices?

Michelle Wang1
Prodigy 110 points
Part Number: SN74LV1T02

Hi there,

I am interested to find out if the component can be used in Class 2 medical devices.

Also if it is possible, the operating relative humidity (RH) and operating pressure.

Thank you!

  • 0
    TI__Guru* 97046 points

    Hello,

    The SN74LV1T02 is not specifically qualified for class 2 medical devices, and I'm afraid I'm not familiar with the requirements to make an IC qualified to be used in a class 2 medical device. From what I found on the FDA website in regards to Class II medical devices, it seems that they classify entire systems -- not individual components like logic gates: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

    If you have more information regarding what being would allow a device to be used in a class 2 medical device, I would be interested to learn about it. From what I saw in my brief research, there aren't any special requirements for ICs.

    The SN74LV1T02 (like most logic devices) is an MSL level 1 device, which means that it can be stored indefinitely at 85% RH before being soldered, but this is only related to the soldering of the device. There's no limitation on RH for operating this device.

    Operating pressure is not specified on any of our logic devices.