In its section on medical device software IEC 62304 requires software unit verification for software of class B and C but does so in a single, terse sentence, "The manufacturer shall perform the software unit verification and document the results." So as an engineer, how do you go about fulfilling this requirement? Two important things need clarification: What is the definition of a software unit in IEC 62304 and what do you need to verify it? The regulation defines a software unit as a software item that is not further decomposed and forms the lowest level of the software system. It should be noted that the standard does say that a software unit cannot be subdivided further. This avoids a contradiction, because elsewhere in the standard it allows the manufacturer to define the granularity of software units.
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