Can I use STM32F103C8 in a Medical Device.

[RKoda.2]

We have built a respirator prototype using a pic microcontroller, which has been tested by doctors and they are satisfied with the results, now we wanted to manufacture the product in a large scale and before that it needs to be certified for IEC 60601. So my question is can I use STM32F103C8 in the product and does it satisfy IEC60601 criteria?

[waclawek.jan]

This is a primarily user-driven forum, with casual ST presence. You need to ask this question ST directly, through web support form, or through FAE.

JW

[Ozone]

A first indicator would be the datasheet / reference manual.

Those documents usually contain a disclaimer describing applications the device is not fit for. Like medical applications.

Usually at the very end - at least the TI documents I vividly remember did so.

As Jan suggested, approach ST directly.

[RKoda.2]

Thank you both for your quick replies. I have asked the question to the ST directly and awiating their reply.

@Ozone​  before posting the question I read the description of STM32F103 in their portfolio and datasheet as well, which states that these microcontrollers can be used in medical devices but I could not find any supporting documents.

[Ozone]

I'm not an expert in this field, but there are several classes.

Many MCU datasheets explicitly state the devices are not appropriate for failsafe devices, e.g. life support.

Something like a blood pressure mesurment device is uncritical in this regard.

[Tesla DeLorean]

I'm not a lawyer : Liability and testing, evaluation, certification burden entirely on YOU

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[Ggrft.1]

Those documents generally include a disclaimer describing packages the device isn't always healthy for. Like clinical packages here. Usually at the very cease - at the least the TI files I vividly keep in mind did so.