類別: STANDARDS

可用性工程

根據IEC 62366-1將人因工程應用於醫療器材。確保器材可被其預期用戶安全有效地使用。FDA和EU MDR對所有器材類別均要求。

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

FDA Human Factors guidance ↗

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