Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
This guidance applies to medical devices, including in vitro diagnostic products and accessories that are either electrically-powered or have functions/sensors implemented using electrical/electronic circuitry. It provides recommendations for EMC information that should be included in premarket submissions to demonstrate electromagnetic compatibility.
Recommended Actions
- Determine device classification and applicable EMC standards based on intended use
- Develop detailed EMC test plan including:
- Device configurations and functions to be tested
- Pass/fail criteria
- Test methods and levels
- Monitoring methods
- Perform comprehensive EMC testing:
- Emissions testing
- Immunity testing
- Testing for common EM emitters if applicable
- Document all test results, modifications, and mitigations
- Prepare EMC-related labeling content
- Include complete EMC information package in premarket submission:
- Device characteristics
- Risk assessment
- Test results
- Labeling
- Any deviations or allowances used
- For IDE/IND submissions, develop appropriate alternative EMC mitigations if needed
- Maintain EMC documentation in design history file
Key Considerations
Non-clinical testing
- EMC testing should be performed on the final finished device
- Testing should be done as a complete system with all accessories and components
- Device should be tested in all intended operating modes and configurations
- Testing should address both emissions and immunity
- Testing should be appropriate for intended use environments (Professional Healthcare, Home Healthcare, Special Environments)
Software
- For devices with software, firmware changes made to pass EMC testing must be documented
- Software changes to address EMC issues must be analyzed for potential impacts on device safety and performance
Labeling
- Must include EMC-related information for safe installation and use
- Specify intended use environments
- List compatible accessories and equipment
- Describe expected behavior if functions are lost/degraded due to EMI
- Include compliance levels for emissions and immunity tests
- Provide precautions regarding EM energy sources
- Include wireless specifications if applicable
- Provide maintenance instructions for EMC
- Include required markings and warnings
Safety
- Must assess risks associated with device malfunction due to EMI
- Must categorize severity of potential harm into three levels:
- Device-related deaths and serious injuries
- Device-related non-serious adverse events
- Device-related events without harm
Other considerations
- Must address common EM emitters not covered by standards (RFID, security systems, etc.)
- Special environments may require additional testing beyond standard requirements
- Modifications made to pass EMC testing must be documented and analyzed
- For IDE/IND submissions, alternative EMC mitigations may be acceptable
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Labeling Requirements and Recommendations for Medical Devices
- Design Controls for Medical Device Manufacturers
Related references and norms
- IEC 60601-1-2: Medical electrical equipment - EMC requirements and tests
- IEC 61326-1: Electrical equipment for measurement, control and laboratory use - EMC requirements
- ISO 14117: EMC test protocols for implantable cardiac devices
- ASTM F2503: Safety marking in the MR environment
- RTCA DO-160: Environmental conditions and test procedures for airborne equipment
Original guidance
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- HTML / PDF
- Issue date: 2022-06-06
- Last changed date: 2022-06-03
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, Errors, Radiology, and Problems, Biologics, Radiological Health, Investigational Device Exemption (IDE), Safety - Issues
- ReguVirta summary file ID: aa59fb8616a07d86d994a526a643d244
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