We are planing to use Freertos in medical device ; but we get mixed about EN62304 ; does that mean freertos deos not meet that standart? or we can use and we have to test it? or its not allowed to use it at all in medical device? i know that safeRtos is an option but its expensive . please guide me
I would imagine that you would go for SafeRTOS incase you need to meet EN62304.
Yes - if your system design relies on the OS for safety functions and you need to certify to EN62304 then you can either do the work necessary to comply with EN62304 yourself, or use SafeRTOS which already has the necessary certification artifacts.
Hello Martin ;
Thank you for the response ; My question is about Freertos and medical devices .
Do you mean that FREERtos dont meet the starndart EN62304? Or I cant use ?
Please could you explain me ?
The biggest thing is that SafeRTOS has gone through the certification while FreeRTOS hasn’t. My understanding is that SafeRTOS IS a slightly different codebase (I think maybe even removing some functionality) with the changes being what was needed to pass the safety standards.
The cost of SafeRTOS is in part to pay for the work that went into that certification.
You are of course free to take FreeRTOS, do the necessary processes to certify it to EN 62304 (possibly needing to make some small modifications) yourself. I suspect if you look at the costs, SafeRTOS is likely cheaper.
Im no expert on this, but I believe that FreeRTOS is not pre-certified for EN 62304. You could probably use it, but you would have to go thru the certification process with the RTOS as a SOUP.
Using SafeRTOS would give you this certification. SafeRTOS is however not free .
I would argue the same. I would rather force myself not to use an RTOS in my product than go through the certification process with a non-certfied RTOS. If i without a doubt would need an RTOS in my product, i would use a pre-certfied.
Thank you again;
Our software department plan to Ibm rhapsody with FreeRtos ; and they claims that its ok . I need to prove them why not ok , they will do the check list of EN62304.
İ want to know if its legal ot not? Does FreeRtos dont let us use it medical ? could you explain pls
The FreeRTOS license is very open source, and puts no restrictions on what you can do with it. The biggest condition on its use is that you give up your right to sue them if there is a problem with the software. If YOUR legal department is willing to let you do the certifications yourself, then as far as I ca see, you can use it. Depending on the level of certification you need, it may well not be just a simple check list to go over, but may require the creation of documentation above what is currently supplied with the FreeRTOS release that you would need to create.