IEC 60601-1-2 is an International EMC standard that specifies Electromagnetic emissions requirements, and Electromagnetic Immunity testing requirements & immunity test levels for Medical Electrical Equipment (ME Equipment) and Medical Electrical Systems (ME Systems). This standard is a collateral standard to the IEC 60601-1. The scope/objective of the IEC 60601-1-2 collateral standard is to outline general requirements and tests for the basic safety and essential performance of ME equipment and ME systems in the presence of electromagnetic disturbances and electromagnetic disturbances emission from ME equipment and ME systems.

Currently, the fourth edition 4.1 of this standard (IEC 60601-1-2:2014+AMD1:2020 CSV, published in 2020) is available and valid. This standard was published by the International Electrotechnical Commission (IEC) published. 

 This collateral standard is used to ensure that the medical equipment and medical systems will operate properly in their intended real-time electromagnetic environment without interfering with other nearby medical equipment & systems, and non-medical equipment (e.g., computers), and telecommunications (e.g., radio/TV, telephone, radio-navigation).

The medical equipment manufacturer needs to show their medical devices or products comply with the requirements of IEC 60601-1-2 to sell their products in the market. 

IEC 60601-1-2 standard use and applicability:

The emission requirements and tests specified by the IEC 6061-1-2 collateral standard are generally applicable to Medical Electrical Equipment and Medical electrical systems. In this standard, tests are described based on where the ME equipment (medical device) is intended to be used. This standard requirements and tests specified are applicable for medical devices intended to be used in the following environments:

• Professional Healthcare Environment – i.e., Hospitals, clinics, other medical facilities 
• Home Healthcare Environment – i.e., Homes, public spaces 
• Special Environments – i.e., Military installations, industrial zones

Emission measurement tests and immunity tests involved (mentioned) in IEC 60601-1-2:

EMC testing involves emission measurement testing and immunity testing. Emissions measurement testing is performed to measure the amount of EMI (electromagnetic interference or RF noise) emitted by a medical device (or medical system). The emission measurement testing ensures that the medical devices or product does not emit harmful EMI and does not cause interference with other electronic devices or systems while operating in the intended real-time environment.  As per IEC 60601-1-2, the following emission measurement tests are conducted on medical devices, typically in a laboratory. During the tests, the device under test (DUT) is in its normal working (ON) state.  

• Conducted RF Emissions (CISPR 11)
• Radiated RF Emissions (CISPR 11)
• Harmonic Distortion (IEC 61000-3-2)
• Voltage Fluctuation and Flicker (IEC 61000-3-3)

Immunity testing is performed in a lab environment to ensure that the medical device (or system) can withstand a specified degree of EMI from other devices while working in the intended real-time environment. In this test, test signals are applied to medical equipment/system to check the immunity of the device against EMI. The IEC 60601-1-2 collateral standard involves the following possible immunity tests as mentioned below:

• Electrostatic Discharges (IEC 61000-4-2)
• Radiated, radio frequency EM Fields immunity test (IEC 61000-4-3)
• Immunity test to Electrical Fast Transients/bursts (IEC 61000-4-4)
• Surges (IEC 61000-4-5)
• Immunity test to conducted Disturbances, induced by RF fields (IEC 61000-4-6)
• Voltage Dips and Interruptions (IEC 61000-4-11)
• Rated Power-frequency Magnetic Field (IEC 61000-4-8)
• Proximity magnetic fields (IEC 61000-4-39)

The following table is provided in the IEC 60601-1-2:2014/AMD1:2020 document:

What are the technical changes in the new edition of IEC 60601-1-2?

The current fourth edition 4.1 (IEC 60601-1-2:2014+AMD1:2020 CSV) cancels and replaces the third edition of IEC 60601-1-2 and features significant technical changes from the previous third edition, which are listed below. 

• specifies immunity test levels according to the environments of the intended use. These environments are categorized in alignment with IEC 60601-1-11 and include professional healthcare facility environments, home healthcare environments, and special environments;
• As compared to immunity test levels specified in the previous third edition, the new edition 4.1 specifies tests and test levels to improve medical electrical equipment and medical electrical systems safety when portable RF communications equipment is used near the medical electrical equipment. 
• provides the specification of immunity tests and immunity test levels based on the ports of the medical electrical equipment or medical electrical system; 
• Specifications of Immunity tests and immunity test levels are provided according to the ports of the ME equipment or ME system;
• This edition specifies immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use. It results in some immunity test levels of this edition are higher than in the previous edition; and

This new edition features the following main additions:

• provides guidance for determining the immunity test levels for special environments;
• specifies guidance for adjustments of immunity test levels when special considerations of mitigations or intended use are applicable;
• provides guidance on risk management for basic safety and essential performance for electromagnetic disturbances; and
• guidance for identification of immunity pass/fail criteria.

Additional information on IEC 60601-1-2:

IEC 60601-1-2 standard requires that manufacturers of Medical devices have to submit a test plan to the accredited test laboratory prior to EMC testing. The test plan include the following details (IEC 60601-1-2; Annex G):

• Test facility name and address
• Medical equipment or Medical system description including basic safety and essential performance description
• Identification of the medical equipment or medical system
• Information about Medical equipment or medical system configurations, settings, operating modes, ME equipment, or ME system power input voltages and frequencies.
• Medical equipment or medical system software/firmware version of the sample to be tested
• Number of samples to be tested for each EMC test
• Information about intended use and intended environments
• Applicable standards and test methods information, i.e., a list of the standards (with dates) and emission limits or immunity test levels.
• Information about deviations from the basic EMC standards
• Applicability/tests that will not be performed. 
• As per RISK Analysis, Immunity pass/fail criteria specification 
• Earthing configuration
• Test setup electrical and physical diagrams. 
• Information about test set-ups such as table-top or floor-standing equipment, or a combination of the two.
• Description about any PATIENT-COUPLED cable terminations to be used
• Description about the simulators, accessories, and auxiliary equipment used, including PATIENT physiological and subsystem simulation.
• Documentation about any special medical equipment or medical system hardware or software needed to perform the tests
• Alarm limit settings If applicable.
• Information about planned ESD test points. If possible, provide a drawing or annotated photo showing the ESD test points.
• Information about the Dwell time for each immunity test requiring a dwell time

The document of the IEC 60601-1-2 standard contains a series of annexes that provide general guidance and include information for test plan contents, determination of immunity test levels for special environments, and immunity pass/fail criteria principles. For example, Annex E of the IEC 60601-1-2:2014+AMD1:2020 CSV provides information for the determination of immunity test levels for special environments.

Note 1: For certain types of medical electrical equipment and medical electrical systems, the requirements specified in this collateral standard might need to be modified by the special requirements of a particular standard. A particular standard is the EMC standard for a specific type of medical equipment/device (e.g., IEC 60601-2-27 is the particular standard for electrocardiographic monitoring equipment).

Note 2: As it is not practical to do so, this collateral standard does not cover all electromagnetic disturbance phenomena. Medical electrical equipment/system manufacturers need to address this during their RISK ASSESSMENT and evaluate if other electromagnetic disturbance phenomena could make their product unsafe.

Details of IEC 60601-1-2:2014+AMD1:2020 CSV document: