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 reviewer 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 about UL's regulatory solutions for medical device manufacturers.