Electromagnetic Compatibility Testing and Safety Requirements for Powered Wheelchairs
This guidance addresses the electromagnetic compatibility (EMC) concerns for powered wheelchairs, specifically focusing on uncontrolled movements when exposed to radio frequencies (RF) and microwave radiation.
Recommended Actions
- Review and document any existing incident reports or complaints related to EMC interference
- Conduct EMC testing across the specified frequency range (1 MHz to 1000 MHz)
- Evaluate wheelchair performance near common RF sources like police/security radios
- Implement technical solutions to prevent unintended movement due to RF interference
- Develop and submit response to FDA within 20 working days including:
- Documentation of any known incidents
- Technical information on EMC solutions
- Action plan for preventing unintended movement
- Consider implementing EMC shielding or other protective measures
- Update risk management documentation to include EMC-related hazards
Key Considerations
Non-clinical testing
- EMC testing across frequencies from 1 MHz to 1000 MHz
- Testing for susceptibility to RF and microwave radiation
- Field strength testing at 10 V/m level
- Testing for interference from medium power hand-held “walkie-talkie” type radios at 450 MHz
Safety
- Prevention of unintended wheelchair movement due to RF interference
- Protection against EMC-induced brake release
- Consideration of safety at distances up to 3 feet from RF sources
Other considerations
- Requirement to report incident reports and complaints related to EMC issues
- 20-working-day response timeline for manufacturers
Relevant Guidances
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles
Related references and norms
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
Original guidance
This post is licensed under CC BY 4.0 by the author.