IEC 60601-2-12 Lung Ventilator Safety Testing
IEC 60601-2-12 specifies particular requirements for the safety and essential performance of critical care ventilators. Compatible Electronics provides testing to this standard at our NVLAP-accredited laboratory, supporting regulatory submissions for these life-supporting devices.
Overview
IEC 60601-2-12 is the particular standard for critical care ventilators intended for use in healthcare facilities. It supplements IEC 60601-1 with requirements specific to ventilatory support equipment, addressing the unique hazards associated with mechanical ventilation of patients who may be dependent on the device for survival.
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 60601-2-12 Ed. 2.0 (2011)
- ISO 80601-2-12 (current edition)
- IEC 60601-1 integration
European
- EN ISO 80601-2-12
- MDR life-supporting requirements
- CE marking for ventilators
North America
- FDA guidance for ventilators
- Emergency Use Authorization (EUA) testing
- ISO 80601-2-12 adoption
Related Standards
- IEC 60601-1-2 (EMC critical care)
- IEC 60601-1-8 (ventilator alarms)
- ISO 18562 (breathing gas pathway)
Get Started Today
Contact our experts for comprehensive testing services.
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