IEC 62366 Templates

These IEC 62366-1 templates support a usability engineering file for medical devices. They provide starting points for defining the use specification and user interface, identifying known and foreseeable use-related hazards, selecting hazard-related use scenarios, planning and recording formative evaluations, and preparing and reporting the final summative evaluation.

Usability engineering is a risk-control process, not a visual-design review. Define the intended users, patients, use environments, training, operating principle, and critical tasks before choosing participants or writing a test script. Connect use errors and interface characteristics to the ISO 14971 risk analysis, and trace evaluation findings to design changes, residual-risk decisions, labelling, and training.

Tailor the templates to the device and the edition of the standards and regulatory guidance that applies. Representative users, realistic environments, production-equivalent interfaces, justified sample sizes, and unbiased protocols matter more than completing every blank. Record deviations and unsuccessful tasks honestly. These examples do not replace IEC 62366-1, its collateral guidance, or professional human-factors judgment; the finished file must show the iterative work and evidence for your actual interface.