Medical Device Safety Compliance Testing (ASCA TL-80)
Compatible Electronics provides comprehensive safety testing for medical electrical equipment. As an FDA ASCA recognized laboratory (TL-80), our safety test reports are accepted directly by FDA, supporting efficient 510(k) submissions.
Our Safety Testing Capabilities
Our NVLAP accredited laboratory performs complete safety evaluations for medical devices per IEC 60601-1 and related standards, addressing electrical, mechanical, thermal, and other hazards to patients, operators, and the environment.
Electrical Safety Testing
Insulation & Protection
- Dielectric strength (hi-pot) testing
- Protective earth continuity
- Insulation resistance measurements
- Creepage and clearance verification
Leakage Current Testing
- Earth leakage current
- Touch (enclosure) leakage current
- Patient leakage current
- Patient auxiliary current
Mechanical Safety Testing
Structural Integrity
- Mechanical strength and stability
- Moving parts hazard evaluation
- Suspended masses testing
- Patient support systems
Surface Safety
- Surfaces, corners, and edges
- Expelled parts protection
- Sharp edges evaluation
- Pinch point assessment
Dynamic Testing
- Acoustic pressure and vibration
- Moving mechanism safety
- Impact and drop testing
- Stress analysis
Ergonomics
- User interface evaluation
- Controls and displays
- Accessibility requirements
- Human factors integration
Environmental and Thermal Testing
Temperature Testing
- Temperature measurements (normal operation)
- Abnormal operation and fault conditions
- Surface temperature limits
- Internal component temperatures
Environmental Protection
- Humidity and spillage resistance
- Ingress protection (IP ratings)
- Cleaning and disinfection compatibility
- Environmental stress testing
Fire Hazard Evaluation
- Fire hazard evaluation
- Materials flammability testing
- Fire enclosure requirements
- Thermal cutoff verification
Storage & Transport
- Storage condition requirements
- Transportation testing
- Packaging integrity
- Environmental range verification
Applied Part Testing
Type B Applied Parts
- Non-critical patient contact
- Standard leakage current limits
- Basic protection level
- General equipment applications
Type BF Applied Parts
- Floating applied part
- Enhanced patient isolation
- Reduced leakage requirements
- Direct patient connection
Type CF Applied Parts
- Cardiac floating protection
- Direct heart connection capability
- Strictest leakage limits
- Highest protection level
Defibrillation Protection
- Defibrillation-proof requirements
- High-energy discharge protection
- Recovery time verification
- Component survival testing
Standards Coverage
Comprehensive Standards Testing
We test to all editions and regional variants of medical device safety standards:
- IEC 60601-1 Ed. 3.1 and Ed. 3.2 - International standard
- ANSI/AAMI ES60601-1 - US national differences
- EN 60601-1 - European harmonized standard
- CAN/CSA-C22.2 No. 60601-1 - Canada
- Collateral standards (60601-1-X series) - Specialized requirements
- Particular standards (60601-2-XX series) - Device-specific standards
FDA ASCA TL-80 recognized for IEC 60601-1 testing
Why Choose Our Safety Testing Services?
FDA ASCA Recognition (TL-80)
Our test reports are accepted by FDA without additional technical review, streamlining your 510(k) submission process.
NVLAP Accredited
ISO/IEC 17025:2017 accredited laboratory ensuring highest quality testing and documentation.
Complete Testing Capabilities
Full electrical, mechanical, thermal, and environmental safety testing under one roof.
Expert Consultation
Experienced engineers provide technical guidance throughout the testing and regulatory process.
Risk Management Support
Integration with ISO 14971 risk management documentation and analysis.
Global Standards Coverage
Testing to international, US, European, and Canadian standards for worldwide market access.
Contact Us for Medical Device Safety Testing
Get comprehensive safety testing from our FDA ASCA recognized laboratory.
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