Whitepaper
IEC : EN 60601-1-2 Implications of 4th the Edition
This whitepaper from York EMC Services details the increased stringency of the latest IEC/EN 60601-1 and IEC/EN 60601-1-2 standards for medical electrical (ME) equipment EMC testing. The core change involves a shift towards risk management; manufacturers must now submit a detailed Risk Management File (RMF) outlining potential EMC phenomena, justification of test levels, operating modes, and separation distances prior to formal compliance testing. Radiated immunity tests are harmonized up to 2.7 GHz, while conducted immunity sees increased levels in ISM/amateur bands (6V). Specific immunity level increases include ESD to ±8kV contact and ±15kV air discharge, and magnetic field immunity to 30 A/m. The paper highlights the need for proactive risk assessment to determine appropriate testing parameters including RF wireless communication proximity fields with minimum separation distances defined within the RMF.