CROSSWALK
IEC 62366 Usability Engineering Crosswalk
Clause-by-clause breakdown of IEC 62366 usability engineering requirements for medical devices. Maps each requirement to ISO 13485 and scanner checks.
Usability Engineering
| IEC 62366 Clause | ISO 13485 Mapping | Requirement | 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 → |
Other standards
Free compliance review. Pay only for the detailed report.
No credit card. No sales call. No consultants required.
Start My Free Review →Read-only access. Your documents stay in your Drive.