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HAL Library for Medical device EN62304

Hector_06
Associate III

Hello Everyone

I dont know if its the correct place to ask .

We design a medical device where EN62304 calss C is applied . the standart says if we use an 3rd party software ( any library ) should be designed to use for medical devices. What about HAL library ?

Thank you in advanced

5 REPLIES 5
Hector_06
Associate III

Any help here ?

I am not a lawyer, this is not legal advice.

This is primarily a user-to-user forum, you're asking the wrong people the wrong question.

ST typically dumps life/safety issues on the device manufacturer (you), and you have to indemnify them. You should check with your sales rep if you use falls within acceptable usage, or what the terms of sale are.

I seriously doubt HAL meets even minimal requirements for medical or aviation usage. Most people in those spaces write and certify their own libraries as they will be the people sued when failure results in loss-of-life.

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Hector_06
Associate III

Thank you for the answer ; TI offers some libraries meets the standarts. I could not find a section in the foru to ask this , event i have a support ticket for week but still no answer from ST.

Writting the libraries fro crash would be not easy . however thank you Clive

Led
Senior

Hi Hector,

How did you proceed with your project? Did you write the HAL on your own? I will have to do the same. In our case I plan do implement the HAL on our own (Class A) as we do not have many peripherals used.

There are several articles for Functional Safety on the ST Website. Have you checked them?

https://www.st.com/content/st_com/en/functionalsafety.html

https://www.st.com/content/ccc/resource/sales_and_marketing/presentation/product_presentation/27/62/14/c9/f2/89/4d/e5/stm32_stm8_functional-safety-packages.pdf/files/stm32_stm8_functional-safety-packages.pdf/jcr:content/translations/en.stm32_stm8_functional-safety-packages.pdf

Maybe it helps.

Best Regards,

Led

Hey, how have you guys dealt with this situation?

I am migrating and upgrading our application (class B) from 8-bit AVR microcontrollers to STM32. I guess it is a matter of documentation and code V&V, do you guys agree?

Another question: do you also use any of the extra safety features like Dual watchdogs or CSS?