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類別: STANDARDS
ISO 14971 (風險管理)
醫療器材風險管理應用的國際標準。ISO 14971涵蓋整個產品生命週期的風險分析、風險評估、風險控制和殘餘風險評估。
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
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