IEC 60601-1-2 is a collateral standard that applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards.
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
Immunity Testing
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
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Test
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3rd Edition
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4th Edition
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AC Emissions, Cispr 11
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Nominal
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Any
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Radiated Emissions, Cispr 11
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Nominal
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Any
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Harmonics, IEC 61000-3-2
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230 V/50 Hz (100V/50 Hz and 100 V/60 Hz occasionally) or rated voltage
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Rated single voltage or 230 V for single-phase, 400 V for 3-phase, 50 or 60 Hz
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Voltage Fluctuations and Flicker, IEC 61000-3-3
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230 V/50 Hz or rated voltage
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Rated single voltage or 230 V for single-phase, 400 V for 3-phase, 50 or 60 Hz
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Electrostatic discharge, IEC 61000-4-2
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Any
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Any
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Radiated RF Immunity, IEC 61000-4-3
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Any
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Any
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Electrical Fast Transients/Burst IEC 61000-4-4
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Lowest and highest rated voltage, any frequency
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Any
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Surge, IEC 61000-4-5
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Lowest and highest rated voltage, any frequency
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Any
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Conducted RF Immunity, IEC 61000-4-6
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Any
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Any
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Power Frequency Magnetics, IEC 61000-4-8
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Any voltage, 50 and 60 Hz
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Any voltage, either 50 or 60 Hz
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Voltages Dips, Dropouts, and Interruptions, IEC 61000-4-11
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Min and max rated voltage, minimum power frequency
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If rated voltage range <25% of lowest rated voltage, any one voltage. Otherwise, lowest and highest rated voltage
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Products Used in Testing:
Amplifier Research
Amplifier Research CI00250A RF Conducted Immunity System
The Model CI00250A is a fully self-contained state of the art system designed to test RF Conducted Immunity. The CI00250A contains all the instruments needed to perform conducted immunity testing to the IEC 61000-4-6...
Compliance West
Compliance West MegaPulse D5-PF Defibrillation Proof Tester
This is an IEC 60601 Defibrillation-proof tester. For the Energy Reduction test, joules consumed in the 100Ω resistor are immediately displayed after each pulse. The MegaPulse D5-PF tests protection against the effects of...
EM TEST
EM Test CWS 500N1 Continuous Wave Simulator, 80W
The CWS 500N1 Continuous Wave Simulator is the most compact single box test equipment for testing conducted RF immunity as per IEC 61000-4-6, 60601-1-2, and related standards with a frequency range of 100kHz to 300MHz. Apart...