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类别: DOCUMENTATION
使用说明(IFU)
随医疗器械提供的包含安全有效使用说明的文件。IFU必须包括预期用途、禁忌症、警告、注意事项和使用方向。所有管辖区均要求。
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
Instructions for Use (IFU) accompany medical devices to enable safe, effective use by the intended user. IFU content is regulated labeling—not marketing copy—and must stay consistent with the cleared/approved intended use and risk file.
PROCESS / STEPS
- Define intended users, use environments, and critical tasks (human factors inputs).
- Draft IFU sections: intended purpose, indications, contraindications, warnings/precautions, step-by-step use, cleaning/reprocessing if reusable, storage, and disposal.
- Align IFU with risk controls (ISO 14971) and clinical evaluation claims.
- Localize languages required by target markets (e.g., JP/CN/EU languages).
- Control revisions under document control; update after design/labeling changes and FSCA.
EXAMPLES
- Reusable surgical instruments need reprocessing instructions validated to standards.
- SaMD IFU often include cybersecurity, update, and clinical decision-support limitations.
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