What are the regulatory requirements for RF emissions from medical devices under IEC 60601?

The regulatory requirements for RF emissions from medical devices are governed by IEC 60601-1-2, the electromagnetic compatibility (EMC) standard for medical electrical equipment. This standard specifies both emission limits (how much unintentional RF energy the device can radiate) and immunity requirements (how well the device resists interference from external RF sources). For emissions, medical devices must meet limits based on their classification: Group 1 devices (not intentionally RF-generating): same limits as CISPR 11/CISPR 32 Class A (for professional healthcare facilities) or Class B (for home healthcare environments). Conducted emissions: 150 kHz-30 MHz, limits of 79 dB(uV) quasi-peak (Class A) or 66 dB(uV) (Class B). Radiated emissions: 30 MHz-1 GHz, limits of 30 dB(uV/m) at 10 m (Class A) or 30 dB(uV/m) at 10 m (Class B). Group 2 devices (intentionally RF-generating, like RF ablation or diathermy): higher emission limits in the ISM band but must still meet limits outside that band. For immunity, medical devices must demonstrate safe operation when exposed to: radiated RF immunity (3-10 V/m, 80 MHz-2.7 GHz), conducted RF immunity (3-10 V rms, 150 kHz-80 MHz), electrostatic discharge (2-8 kV contact, 2-15 kV air), and various other disturbances. Failure of a medical device due to EMI is a potentially life-threatening event, so the standards are more stringent than for consumer electronics.