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IEC 62304 - Segregation and communication between software items

Hello everyone,
after a few months reading your discussions, I have finally decided to start a new one myself. I am a beginner with IEC 62304 and I have a few conceptual questions that I would like to share with the community.

a) The standard defines software items as "any identifiable part of a computer program ". Section 5.3.5 says: "The MANUFACTURER shall identify the segregation between SOFTWARE ITEMS that is essential to RISK CONTROL, and state how to ensure that the segregation is effective."
My understanding is that we have to consider not only the software we write ourselves (e.g. GUI, control unit) but also other elements such as RTOSes, drivers and hypervisors. I can imagine how to ensure segregation between software applications by means of both hardware and software techniques, but I wonder how is it possible to segregate a software application from other items such as RTOSes.

b) What are typical architectures or configurations that one can use in order to have a safe communication between software items? Does anybody know about some related literature?

Many thanks in advance!


Staff member
Super Moderator
I would consider the RTOS SOUP. I wouldn't expect that you'd allocate any risk controls to the RTOS. So I don't think you'd address segregation there.
Not sure about "safe" communication but the standard does talk to communications integrity as part of specifying security requirements. This could be anything from validating inputs, using acks, checksums, encrypted communications, etc.
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