Has the HAL library of STM32 been validated by the medical system,such as IEC 62304

lChen.12 · ‎2023-03-01

Sarra.S · ‎2023-03-01

Hello @lChen.1 and welcome to ST Community,

As mentioned in this thread, some validation reports are available for the STM32Cube HAL & LL drivers. You need to get in contact with your FAE to get them as they are delivered only under a non disclosure agreement "NDA".

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lChen.12 · ‎2023-03-01

I don't know my FAE. How should I contact him

My main objective was to find out if the HAL library passed IDE62304 validation

Sarra.S · ‎2023-03-01

Hello again @AIcha.1,

I escalated your request internally, you will be contacted soon

Thank you.

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Tesla DeLorean · ‎2023-03-01

Can't you run some basic static analysis tools to audit the code/library?

Do a code walk using your own rules and processes?

I'd be seriously uncomfortable using this on life safety critical spaces.

Most people who take this seriously develop their own curated code/library because ST's surely not going to indemnify you.

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Piranha · ‎2023-03-05

If I can point to hundreds of bugs in HAL right away with a finger without even testing, then such a software is terribly broken. The bloat, code style, architecture, development process and testing is also terrible. If it [Edit] can be validated as anything "safe" or even "fine", then it just shows how useless such a validation is!