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 5.5.3: 5.5.3 Software unit acceptance criteria

Acceptance criteria for software units are established before integration into larger items, as appropriate, and units are shown to meet them, such as implementing the requirements including risk control measures, consistency with the documented interfaces, and conformance to coding standards. Applies to classes B and C.

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