Medical Devices and Electromagnetic Compatibility

IEC 60601-1-2, the internationally recognized medical electrical (ME) equipment standard addressing requirements and tests for susceptibility to and immunity from electromagnetic disturbances, has recently undergone an extensive revision to address these new challenges and risks.

Originally published in 2014, the fourth edition of IEC 60601-1-2 has been effective in the U.S., Canada and the European Union (EU) since Dec. 31, 2018. As of that date, jurisdictions of authorities in the U.S. and Canada require new medical devices submitted for regulatory review to demonstrate compliance with the fourth edition’s requirements. In the EU, the IEC 60601-1-2, 4th Edition, is the consensus standard for compliance with the Medical Device Regulation. In 2020, an amendment to IEC 60601-1-2 was published.

This amendment will come into effect on Dec. 17, 2023, in the U.S. In the EU, the amendment will become effective March 19, 2024.

This UL Solutions white paper provides an overview of the fourth edition of IEC 60601-1-2 and its 2020 amendment. The paper begins with a summary of the history of the standard and then offers a detailed review of the significant changes and additions presented in the fourth edition and its amendment.

The white paper also highlights the specific responsibilities that device manufacturers must address before submitting their devices for testing and concludes with other considerations for achieving compliance with the revised standard.