What is the medical standard IEC60601-1?

This page provides a general explanation of medical standards IEC60601 for medical AC/DC power adapters — desktop & wall-mount and medical power supplies.

What is IEC60601?

IEC60601 is a series of technical standards that define the basic performance and safety requirements for electrical equipment intended for medical use. It is published by the International Electrotechnical Commission, with the first edition released in 1977, and has since been updated over time.

As of 2011, in addition to the general standards, it is comprised of approximately 10 collateral standards and about 80 particular standards.

While the IEC60950 standard for IT equipment is well known, the requirements for IEC60601-1 are much stricter compared to it, as it is intended for medical devices that are used in healthcare environments where human safety is at stake.

The following are some representative items that have been revised.

Risk Management (Clause 4.2)

The overview of risk management was revised to clarify how ISO 14971:2007 should be applied. This revision made it clear that full assessment and post-production monitoring based on ISO 14971 are not required for compliance.

Essential Performance (Clause 4.3)

Manufacturers are now required to specify performance limits and evaluate the essential performance characteristics under abnormal conditions or during failures. In addition to these revisions, the essential performance aspect was added as a test criterion when checking for hazards after specific tests. Manufacturers are mandated to clearly state the essential performance conditions in the technical documentation of their product.

Humidity Resistance (Clause 5.7)

The humidity resistance test requirements from IEC 60601-1 Edition 2.0 have been restated.

Documentation (Clause 7)

Numerous documentation requirements have been added for user manuals (IFU) and instructions provided to users. The usability engineering process described in the collateral standard IEC 60601-1-6 has become mandatory when determining the information that must be included in all accompanying electronic documents.

Marking and Labeling (Clause 7.2.2)

It became mandatory for equipment and accessories labels to include unique lot or serial numbers, expiration dates, manufacturing dates, and manufacturer contact information.

Electrical Hazards (Clause 8)

Various modifications were made to protect against risks of electrical hazards, including safety of defibrillators, creepage distances, protective earthing, and clearance. New limit values were set for leakage current tests, which verify if installation connections function properly. Devices with power sockets must now undergo protective earth testing while the power cord is attached. For permanently installed equipment, a power lockout device is required if reconnection could pose a hazard to users.

Mechanical Hazards (Clause 9)

Mechanical hazards testing for portable devices and instability now includes functional testing.

Temperature Tests (Clause 11)

Temperature limits for applied parts were clarified. For overflow, design requirements were introduced to ensure essential performance and basic safety at all times.

Assembly (Clause 15)

“Unacceptable risk” was replaced with “basic safety and essential performance” in relation to mechanical strength. Requirements for transformer assembly reverted to those of IEC 60601-1 Edition 2.0. Compliance with IEC 60086-4 (for primary batteries) and IEC 62133 (for secondary batteries) is now mandatory for lithium batteries.

What is IEC60601-1 Edition 3.1?

IEC 60601-1 Edition 3.1 is a revision published in 2012 to fix numerous issues identified as ambiguous or unclear in the original 2005 third edition. It includes nearly 500 changes and clarifications across a wide spectrum of topics such as temperature testing, risk management, mechanical testing, essential performance, and humidity resistance. Some new standards were also defined for mechanical and electrical hazards.

What is IEC60601-1 Edition 4?

IEC 60601-1-2:2014 Edition 4 was issued in February 2014 as an update to the 2007 Edition 3 of IEC 60601-1-2. It pertains to EMC (electromagnetic compatibility) of medical electrical equipment and systems.

The motivation for this edition was to align safety standards related to electromagnetic disturbances with the general requirements of IEC 60601-1 Edition 3. Older editions of IEC 60601-1-2 did not adequately address safety aspects related to electromagnetic interference. Also, there are significant differences in immunity between Editions 3 and 4.

The foundation of IEC 60601-1 lies in the understanding and management of various risks. This evolved in Edition 3 to define safety-related electrical performance requirements from the perspective of protecting both patients and device users. These factors largely determined specifications for creepage and insulation. Notably, Edition 3.1 addressed several previous definitions to accommodate new technology.

Edition 4 of the EMC collateral standard continues to emphasize risk analysis, but shifts focus away from device categories like “life support” and instead strictly considers “intended use environments.” Specifically, it defines environments such as professional healthcare, home healthcare, and more specialized settings. Professional healthcare includes traditional use in hospitals and similar locations with medical personnel, which now face increased EMC challenges. Home healthcare use covers both non-professional users and unstable electricity availability. “Specialized environments” label high-risk areas like industrial zones and radiotherapy rooms with extreme electromagnetic conditions.

About Unifive's Emissions and Immunity Testing

Here is a brief overview of the emission and immunity test requirements from Edition 4.

As explained above, Edition 4 defines three usage environments: professional healthcare, home healthcare, and specialized environments.

Use in specialized environments is handled through the risk management process and may require application of different test levels/conditions than those indicated in Edition 4.

*ESD levels have increased to ±6 to ±8 kV for contact discharge, and ±8 to ±15 kV for air discharge.

The maximum frequency for radiated immunity testing rose from 2,500 MHz to 2,700 MHz, with a new proximity test added. Test levels were revised, and modulation frequency is now fixed at 1 kHz. The previous 2 Hz modulation for certain devices is no longer specified in Edition 4.

Unifive complies with these emission test definitions.

About Wireless Functions in Medical Devices

When medical devices incorporate wireless modules, IEC/EN 60601-1-2 includes references to the use of wireless communication in medical devices. If national requirements are met, main transmission signals might be exempted from electromagnetic emission limits, but all other emissions must meet the IEC/EN 60601-1-2 limits.

Wireless functionality in medical devices introduces various conditions and testing requirements. With increasing use of IoT in healthcare environments, this topic is receiving attention.

This concludes the chronological overview of medical standards relevant to medical power supplies. Selecting power supplies that comply with medical standards can save time by reducing the need for complex safety testing. Our company offers a wide lineup of such products and continues to focus on developing medical-grade power supplies to meet customer needs.

JIS Standards

In Japan, the new JIS T 0601-1-2:2018 standard has been in effect since March 1, 2018. This standard is similar to IEC Edition 4.0. The transition period ends on February 28, 2023.

Click here for information on JIS standards

What is IEC60601-1-2 Edition 4.1?

IEC60601 Edition 4.1 is a new version of the EMC standard announced around the end of 2020. It is referred to as Edition 4.1 and incorporates Amendment 1 to Edition 4.

Notable changes are as follows:

Specification of Immunity Test Levels

The new version specifies immunity test levels based on intended use environments. These locations are in accordance with IEC 60601-1-11 and are categorized as professional medical environment, medical facility environment, home healthcare environment, and other special environments.

Guidelines on Immunity Test Level Adjustments

Guidelines have been established for adjusting immunity test levels in cases where special consideration is required based on mitigation or intended uses.

Testing Levels for Portable RF Communication Devices

Based on immunity test levels, the previous recommended values from Edition 3 were revised. New tests and levels were stipulated to improve safety of medical electrical equipment and systems when portable RF devices are used in proximity.

Specification of Immunity Test Levels by Environment

Immunity levels have been defined according to the highest reasonably predictable electromagnetic disturbance levels in the respective user environments. Some levels are now set higher than those in the previous edition. Additionally, to better fit the concept of basic safety and essential performance, the term “life support” was removed from the list of defined terms.

Risk Management and Immunity Criteria for Electromagnetic Disturbance

Guidelines were set for risk management related to electromagnetic disturbance for basic safety and essential performance, as well as for determining pass/fail criteria for immunity.

Port-Specific Immunity Requirements

Immunity tests and test levels are now defined based on the ports of medical electrical equipment and systems.

Requirements for Special Environments

Guidelines were defined for determining immunity test levels in special environments.

IEC60601 Edition 4.1 represents a combination of Edition 4 and Amendment 1 (AMD1:2020).