IEC 60601-2-24 Compliance Testing for Infusion Pumps and Controllers
IEC 60601-2-24 specifies particular requirements for the safety of infusion pumps and controllers. Compatible Electronics provides comprehensive testing to this standard at our NVLAP accredited laboratory, supporting regulatory submissions for these critical drug delivery devices.
Overview
IEC 60601-2-24 is the particular standard addressing safety requirements for infusion pumps and infusion controllers used to deliver fluids and medications to patients. It supplements IEC 60601-1 with requirements specific to accurate and safe fluid delivery, addressing hazards such as over-infusion, under-infusion, and air embolism.
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 60601-2-24 Ed. 1.0 (1998)
- IEC 60601-2-24 Ed. 2.0 (2012)
- IEC 60601-1 integration
European
- EN 60601-2-24 (European harmonized)
- MDR compliance
- CE marking requirements
North America
- FDA infusion pump guidance
- AAMI standards
- Pre-market submission requirements
Related Standards
- IEC 60601-1-2 (EMC requirements)
- IEC 60601-1-8 (infusion pump alarms)
- ISO 14971 (drug delivery risk management)
Get Started Today
Contact our experts for comprehensive testing services.
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