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类别: STANDARDS
IEC 60601 (电气安全)
医用电气设备安全性和基本性能的国际标准系列。IEC 60601-1是通用标准；IEC 60601-1-2涵盖电磁兼容性（EMC）。
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 60601 is the core series of standards for basic safety and essential performance of medical electrical equipment. It is widely used for FDA recognition and EU harmonized/state-of-the-art evidence.
PROCESS / STEPS
- Identify applicable collaterals (e.g., 60601-1-2 EMC, 60601-1-6 usability, 60601-1-8 alarms).
- Perform risk management (ISO 14971) linked to essential performance definitions.
- Complete type testing at a competent lab; remediate failures and document residual risks.
- Maintain configuration control when hardware/firmware changes affect compliance.
EXAMPLES
- Patient monitors, infusion pumps, and electrosurgical units typically require IEC 60601 series evidence.
RELATED GUIDES & TOOLS
SOURCES
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