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.
