US Medical Electrical Safety Testing to ANSI/AAMI ES60601-1
ANSI/AAMI ES60601-1 is the US adoption of IEC 60601-1 with national differences specific to the American market. Compatible Electronics provides comprehensive testing to this standard to support your FDA 510(k) submissions.
What is ANSI/AAMI ES60601-1?
ANSI/AAMI ES60601-1 adopts IEC 60601-1 as the base standard and adds US national deviations. These deviations address requirements specific to the US electrical infrastructure, regulatory framework, and healthcare environment. FDA recognizes this as the consensus standard for medical electrical equipment safety.
Key US National Differences
Power Supply
- 120V/60Hz power supply requirements
- US plug and receptacle configurations (NEMA)
- Modified test voltages for US mains
- US mains transient requirements
Components
- UL/CSA component requirements
- UL-listed component review
- Modified protective earth requirements
- Additional construction requirements
Testing Parameters
- US leakage current limits
- NEMA plug/receptacle verification
- 120V/60Hz specific tests
- Modified dielectric strength values
Documentation
- US-specific labeling requirements
- FDA-recognized consensus standard
- 510(k) submission alignment
- AAMI guidance compliance
Testing We Perform
Complete IEC 60601-1 Base Testing
- IEC 60601-1 Ed. 3.1/3.2 full compliance
- All general safety requirements
- Essential performance verification
- Risk management integration
US National Deviation Requirements
- All US national deviation requirements
- 120V/60Hz specific tests
- US mains transient requirements
- US leakage current limits
Component & Construction
- NEMA plug/receptacle verification
- UL-listed component review
- Protective earth evaluation
- US construction requirements
Documentation Support
- Complete test reports
- FDA 510(k) submission support
- Technical file documentation
- Declaration of Conformity assistance
FDA Recognition
FDA-Recognized Consensus Standard
FDA recognizes ANSI/AAMI ES60601-1 as the primary safety standard for medical electrical equipment. Testing to this standard, combined with our FDA ASCA recognition, provides the strongest support for your 510(k) submission.
ASCA-recognized test reports are accepted by FDA without additional review
Related AAMI Standards
General Requirements
- ANSI/AAMI ES60601-1 - General requirements
- All editions covered
- US national deviations included
Collateral Standards
- AAMI/IEC 60601-1-2 - EMC (with US deviations)
- AAMI/IEC 60601-1-6 - Usability
- AAMI/IEC 60601-1-8 - Alarm systems
- AAMI/IEC 60601-1-11 - Home healthcare
Particular Standards
- Particular standards with US deviations
- Device-specific requirements
- Integration with general standard
Our Capabilities
- FDA ASCA recognized (TL-80)
- NVLAP accredited
- All AAMI standards covered
Why Test to ES60601-1?
FDA-Recognized Standard
ANSI/AAMI ES60601-1 is recognized by FDA as the consensus standard for medical electrical equipment safety, providing regulatory confidence.
Required for US Market
Testing to this standard is essential for US market access and addresses US-specific electrical infrastructure requirements.
Comprehensive Safety Evaluation
Covers all aspects of medical device safety including electrical, mechanical, thermal, and radiation hazards.
ASCA-Accepted Reports
Our FDA ASCA recognition means faster 510(k) review with test reports accepted without additional FDA evaluation.
Contact Us for ANSI/AAMI ES60601-1 Testing
Get FDA-recognized testing for your medical electrical equipment from our ASCA-recognized laboratory.
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