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IEC 62304 (医疗器械软件)
医疗器械软件生命周期过程的国际标准，涵盖软件开发策划、需求分析、架构设计、实现、测试和维护。
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 (医疗器械软件) across 27 authorities in real time.
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