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Visitor II
September 9, 2021
Question

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

  • September 9, 2021
  • 3 replies
  • 1199 views

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.

    ST Employee
    September 9, 2021

    Here are some info about medical IEC 62304 in this presentation

    Ebakk.1Author
    Visitor II
    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.