UL's EMC testing services

FDA EMC requirements

UL's EMC facilities can perform tests for expanded EMC requirements under both the International Electrotechnical Commission (IEC) IEC60601-1-2 Standard and the FDA's Reviewers Guidance for Premarket Notification Submissions issued by the Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory, and Neurological Devices. These services include:

• Complete testing to all FDA requirements
• Consultation on appropriate pass/fail criteria for FDA immunity testing
• Preparation of formal EMC reports for submittal to the FDA

Additional Resources

• Learn more: UL's regulatory solutions for medical device manufacturers