Medical Device EMC Testing for Regulatory Submissions

FDA ASCA-Recognized Medical Device EMC Testing Services

Compatible Electronics provides comprehensive electromagnetic compatibility (EMC) testing for medical devices. As an FDA ASCA recognized laboratory, our EMC test reports support streamlined regulatory submissions for both domestic and international markets.

Our Medical EMC Testing Capabilities

Our NVLAP accredited laboratory offers complete EMC testing services for medical electrical equipment, covering emissions and immunity requirements per IEC 60601-1-2 and related standards.

Emissions Testing

Radiated Emissions

Radiated emissions (9 kHz - 40 GHz)
CISPR 11 Group 1 and Group 2 classifications
Class A and Class B emission limits
Professional and home environment testing

Conducted Emissions

Conducted emissions (150 kHz - 30 MHz)
Power line disturbance measurement
Harmonic current emissions (IEC 61000-3-2)
Voltage fluctuations and flicker (IEC 61000-3-3)

Immunity Testing

ESD & RF Immunity

Electrostatic discharge (ESD) up to ±30 kV
Radiated RF immunity (80 MHz - 6 GHz, 1-30 V/m)
Proximity field immunity from wireless devices
Conducted RF immunity (150 kHz - 80 MHz)

Transient Immunity

Electrical fast transient (EFT/Burst)
Surge immunity (lightning, switching)
Voltage dips, sags, and interruptions
Power quality disturbances

Magnetic Fields

Power frequency magnetic field immunity
Low frequency magnetic fields
Environmental magnetic field testing
MRI environment considerations

Wireless Coexistence

Proximity field testing
RF wireless equipment immunity
Multiple wireless technology testing
Healthcare facility RF environment

Medical Device Categories We Test

Life-Supporting Equipment

Critical care ventilators
Cardiac defibrillators
Anesthesia systems
Enhanced immunity requirements

Patient Monitoring Devices

Vital signs monitors
ECG/EKG systems
Pulse oximeters
Continuous monitoring systems

Therapeutic Equipment

Infusion pumps
Surgical equipment
Imaging systems
Therapeutic devices

Laboratory & IVD Equipment

Clinical analyzers
Diagnostic systems
Point-of-care devices
Lab automation equipment

Home Healthcare Devices

CPAP/BiPAP devices
Home monitors
Diabetes management
Wearable medical devices

Diagnostic Imaging

Ultrasound systems
X-ray equipment
MRI compatible devices
Imaging accessories

Intended Use Environment Testing

Professional Healthcare Facility

Hospital and clinic environments
Higher immunity test levels
Professional use scenarios
Complex electromagnetic environment

Home Healthcare Environment

Residential electromagnetic environment
Consumer electronics proximity
Varied electrical installations
Non-professional user context

Special Environments

MRI rooms (high magnetic fields)
Surgical suites (RF equipment)
Emergency medical services
Transport and ambulance use

Test Level Selection

Environment-specific test levels
Life-supporting equipment criteria
Essential performance verification
Risk-based approach

Essential Performance Evaluation Support

Risk-Based EMC Testing Approach

IEC 60601-1-2 Edition 4 requires identification of essential performance - the clinical functions that must be maintained during and after EMC disturbances. We work with manufacturers to properly identify and document essential performance, then verify it throughout the EMC test program.

Essential performance verification is fundamental to Edition 4 compliance and regulatory acceptance