Whitepaper
New Requirements for Medical EMC
This whitepaper details the changes introduced by the 4th edition of IEC 60601-1-2, the standard for electromagnetic compatibility (EMC) of medical electrical (ME) equipment. Key updates include the elimination of the “life-supporting” equipment category and a greater emphasis on defining environments of intended use – professional healthcare, home healthcare, and special environments – impacting testing requirements. The 4th edition significantly strengthens the Risk Management File (RMF), requiring detailed documentation of risk assessments, pass/fail criteria for both safety & performance related to EMC, and justification for test levels. A pre-submission test plan based on the RMF is also mandated. The paper highlights that compliance with this standard was required by December 31, 2018, impacting manufacturers globally.