CROSSWALK
IEC 62366 Usability Engineering Crosswalk
Where IEC 62366 usability engineering meets ISO 13485 — use specification through summative evaluation, clause by clause, and what the scanner looks for in each.
Group by:
Design & Development
| IEC 62366 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §4.1.1 | 7.3.2 | Usability Engineering Process | 2 | View → |
| §4.2 | 4.2.4 | Usability Engineering File | 1 | View → |
| §5.1 | 7.3.3 | Use Specification | 1 | View → |
| §5.3 | 7.1 | Identify known or foreseeable Hazards and Hazardous Situations | 2 | View → |
| §5.7 | 7.3.6 | Establish User Interface Evaluation plan | 1 | View → |
| §5.9 | 7.3.7 | Perform Summative Evaluation of the Usability of the User Interface | 4 | View → |
| §5.10 | 7.3.7 | User Interface of Unknown Provenance (UOUP) | — | View → |
| §4.1.2 | 7.3.2 | RISK CONTROL as it relates to USER INTERFACE design | 2 | View → |
| §4.1.3 | 7.3.3 | Information for SAFETY as it relates to USABILITY | 2 | View → |
| §5.2 | 7.3.3 | Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS | 2 | View → |
| §5.4 | 7.3.3 | Identify and describe HAZARD-RELATED USE SCENARIOS | 2 | View → |
| §5.5 | 7.3.6 | Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION | 2 | View → |
| §5.6 | 7.3.3 | Establish USER INTERFACE SPECIFICATION | 2 | View → |
| §5.8 | 7.3.4 | Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION | 3 | View → |
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