What is the medical standard IEC60601-1?

This page provides a general explanation of the medical standard 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 essential performance and safety of electrical equipment intended for medical use. Published by the International Electrotechnical Commission, the first edition was released in 1977 and has been updated over time to reflect current needs.

In 2011, the general standard was expanded to include around 10 collateral standards and approximately 80 particular standards.

While the standard for IT equipment, IEC60950, is widely known, medical equipment is intended for use in environments where safety is critical, so the requirements of IEC60601-1 are stricter.

Below are some representative items that have been revised.

Risk Management (Section 4.2)

The overview of risk management was revised to clarify how to apply ISO 14971:2007. This clarification specified that a full assessment and post-market surveillance based on ISO 14971 are not required for compliance.

Essential Performance (Section 4.3)

Manufacturers are now required to define performance limit values and evaluate the characteristics of essential performance under abnormal or fault conditions. In addition, when investigating the presence of hazards after specific tests, essential performance was added as a test criterion. Manufacturers must clearly specify essential performance conditions in the product's technical description.

Moisture Resistance (Section 5.7)

The requirements for moisture resistance testing from IEC 60601-1 Edition 2.0 were restated.

Documentation (Clause 7)

Many new documentation requirements were added for instructions for use and manuals for users. Additionally, when preparing all accompanying electronic documentation, the usability engineering process from IEC 60601-1-6 was mandated to determine what information must be included.

Marking and Labeling (Section 7.2.2)

Labels on equipment and accessories must include unique lot or batch numbers, serial numbers, expiration dates, manufacturing dates, and manufacturer contact information.

Electrical Hazards (Clause 8)

Many changes were made to prevent risks from electrical hazards such as defibrillator protection, creepage distances, protective grounding, and clearance distances. New leakage current limits were set to confirm proper grounding. Equipment with power supply sockets must be tested for protective grounding with power cords attached. Permanently installed equipment must include a power lockout mechanism if reconnection could pose a hazard to users.

Mechanical Hazards (Clause 9)

Tests for mechanical hazards related to portable devices and stability were updated to include functional tests.

Temperature Testing (Clause 11)

Temperature limits for contact parts were clarified. Devices must be designed to maintain essential performance and basic safety even during overflow conditions.

Assembly (Clause 15)

“Unacceptable risk” was revised to “basic safety and essential performance” for mechanical strength. Transformer requirements reverted to those in IEC 60601-1 Edition 2.0. Compliance with IEC 60086-4 (for primary batteries) and IEC 62133 (for secondary batteries) is required for lithium batteries.

What is IEC60601-1 Edition 3.1?

IEC 60601-1 Edition 3.1 is a 2012 revision of the original 2005 Edition 3.0, created to correct ambiguities and unclear aspects. Edition 3.1 includes nearly 500 changes and clarifications across topics like temperature testing, risk management, mechanical testing, essential performance, and moisture resistance. It also introduced new standards for mechanical and electrical hazards.

What is IEC60601-1 Edition 4?

IEC 60601-1-2:2014 Edition 4 was released in February 2014 and is an update to the 2007 Edition 3. This edition addresses EMC for medical electrical devices and systems.

The purpose of this edition was to align electromagnetic disturbance safety standards with the general requirements of Edition 3 of IEC 60601-1. Previous versions did not adequately address safety aspects related to electromagnetic interference. Significant differences exist between Edition 3 and Edition 4 concerning immunity.

The fundamental premise of IEC 60601-1 is an understanding and management of risks. Edition 3 expanded on this by defining electrical performance requirements that ensure safe operation for both patients and users. These factors helped decide specifications for creepage, clearance, and insulation. Edition 3.1 further clarified previous definitions to accommodate technological advancements.

Edition 4's EMC collateral standard continues to emphasize risk analysis while moving away from categories like "life support" and instead strongly considers "intended use environments." It defines three usage environments: professional healthcare, home healthcare, and more specialized environments. Professional healthcare covers traditional use in hospitals and similar environments, which pose increasing EMC challenges. Home healthcare must address both non-professional users and unstable power conditions. Specialized environments include areas like industrial zones or radiation treatment rooms with high levels of electromagnetic disturbances.

Unifive’s Emission and Immunity Testing

Below is an overview of the emission and immunity test requirements in Edition 4.

As described above, Edition 4 defines three usage environments based on device application: professional healthcare, home healthcare, and special environments.

Specifically, use in special environments is addressed through the risk management process. Different test levels and conditions may apply compared to those in Edition 4.

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

The maximum frequency for radiated immunity increased from 2,500 MHz to 2,700 MHz, with a new "proximity" test added. Test levels also changed, with modulation frequency fixed at 1 kHz. The previously specified 2 Hz modulation for some equipment is no longer used in Edition 4.

Unifive complies with these emission test definitions.

Wireless Features in Medical Devices

If a wireless module is built into a medical device, IEC/EN 60601-1-2 addresses the use of wireless communication. If national requirements are met, exemptions for primary transmission signal emissions may apply. However, all other emissions must conform to IEC/EN 60601-1-2 electromagnetic emission limits.

Various additional requirements and test details apply to medical devices with wireless functionality. With the growing presence of IoT in healthcare, this item is gaining increasing attention.

We’ve introduced medical power regulations in chronological order. Selecting power supplies compliant with medical standards helps reduce time spent on complex safety testing. We offer a wide product lineup and are committed to continually developing medical power supplies that meet customer needs.

JIS Standards

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

Click here for more on JIS standards

What is IEC60601-1-2 Edition 4.1?

IEC60601 Edition 4.1 is a newer version of the EMC standard announced around the end of 2020. It is referred to as Edition 4.1 due to the inclusion of Amendment 1 to Edition 4.

Representative changes include the following:

Specification of Immunity Test Levels

The new version defines immunity test specifications according to the intended environment of use. Usage locations are categorized in compliance with IEC 60601-1-11 into professional medical environments, medical facility environments, home healthcare environments, and other specialized environments.

Guidelines for Immunity Test Level Adjustments

Guidance was established for modifying immunity test levels when applying specific considerations such as mitigation or intended use.

Test Levels for Portable RF Communication Devices

New test procedures and levels were established to enhance the safety of medical electrical devices and systems when portable RF communication equipment is used nearby—closer than recommended in Edition 3.

Immunity Test Levels For Each Intended Environment

Test levels are now aligned to the maximum reasonably foreseeable electromagnetic disturbances in each usage environment, resulting in higher specified immunity levels than the previous version. Additionally, the term "life support" was removed to better align with concepts of basic safety and essential performance.

Risk Management and Immunity Criteria for Electromagnetic Disturbances

Guidelines were established on managing risk related to electromagnetic disturbances for basic safety and essential performance, along with criteria for determining pass/fail outcomes in immunity testing.

Immunity Criteria Based on Ports

Immunity tests and levels were specified based on the ports of the medical electrical device or system.

Regulations for Special Environments

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

IEC60601 4.1 Edition is composed of two documents: the 4th Edition and Amendment 1:2020, together forming Edition 4.1.