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 5.7.1: 5.7.1 Establish tests for software requirements

For software system testing, a set of tests covering every software requirement is defined and run, each stated in terms of inputs, expected results, pass or fail criteria and procedure, and the suitability of the verification strategies and test procedures is evaluated. Requirements may also be tested at earlier stages or in combination. Applies to classes A, B and C.

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