IEC Standards: IEC 60601-1-2: Medical Electrical Equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests

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

  • Modes that maximize emissions

  • Consider active and standby modes

Immunity Testing

  • Standby mode should be considered

  • Devices not rated for continuous use and use a duty cycle

Product Configuration for Testing

  • All cables, tubing, and fluid containers necessary for the intended use must be attached and full, including system grounds when present

  • Artificial hand circuit (220pF + 510Ω)

  • Special hardware of 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

230V/50Hz (100V/50Hz and 100V/60Hz occasionally) or rated voltage

Rated single voltage or 230V for single-phase, 400V for 3-phase, 50 or 60 Hz

Voltage Fluctuations and Flicker, IEC 61000-3-3

230V/50Hz or rated voltage

Rated single voltage or 230 V for single-phase, 400V 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