Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements

What You Need to Know? 👇

What are the key EMC testing requirements for medical devices under the new FDA guidance?

The guidance requires EMC testing using FDA-recognized consensus standards like IEC 60601-1-2 for non-implantable devices and ISO 14117 for AIMDs. Testing must demonstrate immunity to electromagnetic disturbances and acceptable emissions levels in intended use environments.

How do I determine Essential Performance for my medical device’s EMC evaluation?

Essential Performance is clinical function performance where loss or degradation results in unacceptable risk. Identify clinical functions, specify performance limits, and evaluate risks from loss or degradation. If risk is unacceptable, it’s Essential Performance.

What environments must be considered for medical device EMC testing?

Three environments: Professional Healthcare Facility (hospitals, clinics), Home Healthcare (residences, outdoor areas), and Special Environment (aircraft, MRI areas, military zones). Each has different electromagnetic characteristics requiring specific testing considerations.

When can I use allowances or deviations from EMC consensus standards?

Allowances are permitted variations specified within standards and can be used if all conditions are satisfied. Deviations are intentional non-compliance requiring scientific justification that safety/performance isn’t adversely impacted.

What EMC information must be included in medical device labeling?

Include environments of use, compatible accessories, function descriptions during EMI, compliance levels, precautions for EM energy sources, wireless specifications, maintenance instructions, and appropriate MRI safety markings per ASTM F2503.

How should I address common EM emitters not covered by consensus standards?

For high-risk devices, perform specific immunity testing for emitters like RFID, 5G, or electrocautery using available standards or equivalent methods. Include specific labeling warnings and mitigations based on risk analysis and intended use environments.

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What You Need to Do 👇

Recommended Actions

1. Determine device classification and applicable EMC standards based on intended use
2. Develop detailed EMC test plan including:
   • Device configurations and functions to be tested
   • Pass/fail criteria
   • Test methods and levels
   • Monitoring methods
3. Perform comprehensive EMC testing:
   • Emissions testing
   • Immunity testing
   • Testing for common EM emitters if applicable
4. Document all test results, modifications, and mitigations
5. Prepare EMC-related labeling content
6. Include complete EMC information package in premarket submission:
   • Device characteristics
   • Risk assessment
   • Test results
   • Labeling
   • Any deviations or allowances used
7. For IDE/IND submissions, develop appropriate alternative EMC mitigations if needed
8. 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

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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

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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 ID: aa59fb8616a07d86d994a526a643d244