IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 7: software risk management process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 7.1.2: 7.1.2 Identify potential causes of contribution to a hazardous situation

For each such software item the potential causes of its contribution to a hazardous situation are identified, considering incorrect or incomplete specification of functionality, software defects, failure or unexpected results from SOUP, hardware failures or other software defects causing unpredictable operation, and reasonably foreseeable misuse. Applies to classes B and C.

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