IEC62366 clauses 5.2 - 5.4 talk about UI characteristics related to safety, identifying hazards related to the use of device, and find out reasonably foreseeable hazard related use scenarios, and picking the right ones for summative test.
For a start-ups, is there a way to do this in a lean manner without back and forth tracing between usability engineering and risk file, especially where almost the same small team is working with requirements, risk and usability?
Would the following work:
5.2 Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- List these in usability file. Optionally perform task analysis depending on the complexity of the device.
5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
- Reference to risk file. During the risk analysis, consider the characteristics from 5.2 and other aspects of use error sources for risk.
5.4 Identify and describe HAZARD-RELATED USE SCENARIOS and 5.5 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
- No other scenario definition than mitigation related use scenarios documented in summative test plan as test scenarios, (picked based on foreseeable harm from risk file).
Or is there another way to interpret and implement the related clauses in smart manner?
Thoughts?
For a start-ups, is there a way to do this in a lean manner without back and forth tracing between usability engineering and risk file, especially where almost the same small team is working with requirements, risk and usability?
Would the following work:
5.2 Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- List these in usability file. Optionally perform task analysis depending on the complexity of the device.
5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
- Reference to risk file. During the risk analysis, consider the characteristics from 5.2 and other aspects of use error sources for risk.
5.4 Identify and describe HAZARD-RELATED USE SCENARIOS and 5.5 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
- No other scenario definition than mitigation related use scenarios documented in summative test plan as test scenarios, (picked based on foreseeable harm from risk file).
Or is there another way to interpret and implement the related clauses in smart manner?
Thoughts?
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