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CATÉGORIE: STANDARDS

IEC 60601 (Sécurité électrique)

La série de normes internationales pour la sécurité et les performances essentielles des équipements électriques médicaux.

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

  1. Identify applicable collaterals (e.g., 60601-1-2 EMC, 60601-1-6 usability, 60601-1-8 alarms).
  2. Perform risk management (ISO 14971) linked to essential performance definitions.
  3. Complete type testing at a competent lab; remediate failures and document residual risks.
  4. 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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TERMES CONNEXES

ISO 14971 (Gestion des risques)ISO 13485