IEC 60601-2-4 Medical Device Testing for Defibrillators
IEC 60601-2-4 specifies particular requirements for the safety of cardiac defibrillators. Compatible Electronics provides comprehensive testing to this standard at our NVLAP accredited laboratory, supporting regulatory submissions for these life-critical devices.
Overview
IEC 60601-2-4 is the particular standard addressing safety requirements for cardiac defibrillators, including both automatic external defibrillators (AEDs) and manual defibrillators used in clinical settings. It supplements IEC 60601-1 with requirements specific to the delivery of high-energy electrical pulses to the patient's heart.
Testing Services
Comprehensive Testing
Complete evaluation of your medical devices to ensure regulatory compliance and patient safety.
Expert Analysis
Our experienced engineers provide detailed technical analysis and documentation for your regulatory submissions.
Regulatory Support
Support for FDA 510(k), CE marking, and other global regulatory requirements.
Quick Turnaround
Efficient testing processes to meet your development timelines and market launch goals.
Standards We Test To
International
- IEC 60601-2-4 Ed. 2.0 (2010)
- IEC 60601-2-4 Ed. 3.0 (2020)
- IEC 60601-1 integration
European
- EN 60601-2-4 (European harmonized)
- MDR life-supporting device requirements
- CE marking compliance
North America
- FDA guidance for defibrillators
- ANSI/AAMI DF80 (AEDs)
- Over-the-counter AED requirements
Related Standards
- IEC 60601-1-2 (EMC for emergency)
- IEC 60601-1-8 (alarm systems)
- ISO 14971 (critical device risk management)
Get Started Today
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