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类别: STANDARDS
ISO 14971 (风险管理)
医疗器械风险管理应用的国际标准。ISO 14971涵盖整个产品生命周期的风险分析、风险评估、风险控制和残余风险评估。
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
ISO 14971 is the risk management standard for medical devices across the lifecycle—from design hazards to production and postmarket information.
PROCESS / STEPS
- Identify hazards and hazardous situations.
- Estimate and evaluate risks; implement risk controls.
- Assess residual risk and overall benefit-risk.
- Link production and PMS feedback into the risk file.
EXAMPLES
- A design change triggers risk file update and possibly new verification.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to ISO 14971 (风险管理) across 27 authorities in real time.
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