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類別: STANDARDS
IEC 62304 (醫療器材軟體)
醫療器材軟體生命週期過程的國際標準，涵蓋軟體開發策劃、需求分析、架構設計、實現、測試和維護。
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
IEC 62304 defines medical device software lifecycle processes—development planning, requirements, architecture, implementation, verification, and maintenance—used globally as a state-of-the-art reference.
PROCESS / STEPS
- Assign software safety classification.
- Plan SOUP/OTS management and risk controls.
- Execute verification/validation appropriate to class.
- Maintain problem resolution and change control post-release.
EXAMPLES
- Embedded device firmware and SaMD backends both commonly claim IEC 62304 alignment.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to IEC 62304 (醫療器材軟體) across 27 authorities in real time.
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