IEC 60601
Medical electrical equipment — General requirements for basic safety and essential performance
Foundational electrical-safety and EMC standard for medical electrical equipment — required for virtually every powered medical device.
IEC 60601-1 (4th edition, 2024) defines basic safety and essential performance for medical electrical equipment. Collateral standards add cross-cutting topics (-1-2 EMC, -1-6 usability, -1-8 alarms, -1-9 environmentally-conscious design, -1-11 home-use, -1-12 emergency medical services). Particular standards (60601-2-XX) cover specific device types — infusion pumps, defibrillators, MRI, surgical lasers.
A compliant 60601 test report is a non-negotiable input to 510(k), PMA, CE Marking under MDR and most other major-market submissions.
- IEC 60601-1:2024
- IEC 60601-1-2 (EMC)
- IEC 60601-1-6 (usability)
Free trial, no credit card, onboard in days, not months.