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类别: STANDARDS
可用性工程
根据IEC 62366-1将人因工程应用于医疗器械。确保器械可被其预期用户安全有效地使用。FDA和EU MDR对所有器械类别均要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Usability engineering (IEC 62366 / FDA human factors) reduces use-related hazards. Required evidence depth scales with risk of use error—especially for home-use and high-risk devices.
PROCESS / STEPS
- Identify critical tasks and use-related hazards from risk management.
- Conduct formative studies; iterate UI/IFU design.
- Perform summative validation with representative users and use environments.
- Document residual use risks and training/labeling mitigations.
EXAMPLES
- Home-use injectors and infusion pumps almost always need robust human factors validation packages.
RELATED GUIDES & TOOLS
SOURCES
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