IEC 60601-2-35 Testing for Medical Heating Blankets, Pads, and Mattresses
IEC 60601-2-35 specifies particular requirements for the safety of blankets, pads, and mattresses intended for heating in medical use. Compatible Electronics provides testing to this standard at our NVLAP accredited laboratory.
Overview
IEC 60601-2-35 is the particular standard addressing safety requirements for electrically heated blankets, pads, and mattresses used for patient warming in medical settings. It supplements IEC 60601-1 with requirements specific to temperature control, burn prevention, and the safe application of therapeutic heat to patients.
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 60601-2-35 Ed. 1.0 (1996)
- IEC 60601-2-35 Ed. 2.0 (2009)
- IEC 60601-1 integration
European
- EN 60601-2-35 (European harmonized)
- Medical blanket/pad requirements
- CE marking compliance
North America
- FDA guidance for patient warming
- ANSI/AAMI standards
- Temperature control requirements
Related Standards
- IEC 60601-1 (general safety)
- IEC 60601-1-2 (EMC)
- ISO 14971 (thermal hazard management)
Get Started Today
Contact our experts for comprehensive testing services.
www.celectronics.com
