IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.5.4: Additional software unit acceptance criteria

What does 5.5.4 require?

Where the design includes them, further acceptance criteria for units cover: correct sequencing of events; data flow and control flow; planned allocation of resources; handling of faults (defining, isolating and recovering from errors); initialising variables; self-diagnostics; managing memory and overflows; and boundary conditions. Applies to class C.

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