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Ebakk.1
Associate
September 9, 2021
Question

Need info about STM32 MCU usage under Medical Device Regulation class IIb

We want to use a STM32L1 MCU in a medical device class iib. Does anyone have some experience with this. I know that STM supports SIL level MCU support, but where can I find info regarding the usage for Medical devices ?

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3 replies

ST Employee
September 9, 2021

Hello @Ebakk.1​ 

On ST side, please have a look at safety page. Even if L0 & L1 have very similar HW support, STM32L1 family is older and not part of supported devices by X-CUBE-STL. ST recommend to switch to L4 or L0 series.

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ST Employee
September 9, 2021

Here are some info about medical IEC 62304 in this presentation

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Ebakk.1
Ebakk.1Author
Associate
September 9, 2021

Hi Bruno,

Thnx for the info. Ofcourse I did look on the side but could not find the info. Thnx for pointing me out in the right direction !

Might get back to you when other safety related questions arise if you don't mind.