IEC 60601-1-2: Medical Electrical Equipment - Collateral standard: Electromagnetic compatibility...
Standard Overview
This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.
The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This standard complements IEC 60601-1 and applies to all medical devices.
IEC 60601-1-2 is useful for the protection of safety services, other medical electrical equipment and systems, non-medical electrical equipment (e.g. computers), and telecommunications (radio/TV, telephone, radio-navigation).
Emissions Testing
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Modes that maximize emissions
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Consider active and standby modes
Immunity Testing
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Standby mode should be considered
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Devices not rated for continuous use and use a duty cycle
Product Configuration for Testing
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All cables, tubing, and fluid containers necessary for the intended use must be attached and full, including system grounds when present
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Artificial hand circuit (220 pF + 510 Ω)
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Special hardware or software may be required
Test AC Voltage and Power Frequency
Test |
3rd Edition |
4th Edition |
AC Emissions, Cispr 11 |
Nominal |
Any |
Radiated Emissions, Cispr 11 |
Nominal |
Any |
Harmonics, IEC 61000-3-2 |
230 V/50 Hz (100V/50 Hz and 100 V/60 Hz occasionally) or rated voltage |
Rated single voltage or 230 V for single-phase, 400 V for 3-phase, 50 or 60 Hz |
Voltage Fluctuations and Flicker, IEC 61000-3-3 |
230 V/50 Hz or rated voltage |
Rated single voltage or 230 V for single-phase, 400 V for 3-phase, 50 or 60 Hz |
Electrostatic discharge, IEC 61000-4-2 |
Any |
Any |
Radiated RF Immunity, IEC 61000-4-3 |
Any |
Any |
Electrical Fast Transients/Burst IEC 61000-4-4 |
Lowest and highest rated voltage, any frequency |
Any |
Surge, IEC 61000-4-5 |
Lowest and highest rated voltage, any frequency |
Any |
Conducted RF Immunity, IEC 61000-4-6 |
Any |
Any |
Power Frequency Magnetics, IEC 61000-4-8 |
Any voltage, 50 and 60 Hz |
Any voltage, either 50 or 60 Hz |
Voltages Dips, Dropouts, and Interruptions, IEC 61000-4-11 |
Min and max rated voltage, minimum power frequency |
If rated voltage range <25% of lowest rated voltage, any one voltage. Otherwise, lowest and highest rated voltage |
Products Used in Testing
Amplifier Research CI00250A RF Conducted Immunity System
EM Test CWS 500N1 Continuous Wave Simulator, 80W
- Signal generator 9kHz to 1GHz
- Amplitude modulation: 1Hz to 3kHz (0% to 95%)
- Pulse modulation: 1Hz - 1kHz (10% to 90%)
Compliance West MegaPulse D5-PF Defibrillation Proof Tester
- Direct Joules readout on front panel after Energy Reduction Test.
- Increased accuracy in accordance with IEC 60601-2-25 and -2-27:2011 requirements.
- 20 second period between pulse delivery,
Advanced Amplifiers AA-16G-150 Solid State Amplifier | 1.0 - 6.0 GHz, 150 W
- 3U Bench Top or Rack mounted system
- Class AB linear GaN design
- Instantaneous ultra wide bandwidth