High Frequency Surgical Equipment Safety Testing to IEC 60601-2-2
IEC 60601-2-2 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Compatible Electronics provides comprehensive testing to this standard at our NVLAP accredited laboratory.
Overview
IEC 60601-2-2 is the particular standard within the IEC 60601 series that addresses high frequency (HF) surgical equipment used for cutting, coagulation, and other electrosurgical procedures. It supplements IEC 60601-1 with additional safety requirements specific to the hazards of electrosurgical energy delivery.
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 60601-2-2 Ed. 5.0 (2009)
- IEC 60601-2-2 Ed. 6.0 (2017)
- IEC 60601-1 integration
European
- EN 60601-2-2 (European harmonized)
- MDR compliance
- CE marking requirements
North America
- ANSI/AAMI standards
- FDA guidance for electrosurgery
- UL compliance
Related Standards
- IEC 60601-1-2 (EMC for surgical environments)
- IEC 60601-1 (general safety)
- ISO 14971 (risk management)
Get Started Today
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