What is the medical standard IEC60601-1?

This page provides a general explanation of the medical standard IEC60601 for medical AC/DC Power Adapter and medical power supplies.

What Is IEC 60601?

IEC 60601 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 technological advances.

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

The standard for IT equipment, IEC 60950, is well known; however, compared to that, medical devices are intended for use in medical settings where human safety is involved, and therefore the requirements of IEC 60601-1 are more stringent.

Below are some of the major 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 clarified that a complete assessment and post-production monitoring based on ISO 14971 are not required for compliance.

Essential Performance (Clause 4.3)

Manufacturers are now required to define limits for specific performance and evaluate essential performance characteristics under abnormal conditions or during faults. In addition to these revisions, "essential performance" was added to the test criteria used to investigate whether hazards exist after specific tests. Manufacturers are required to clearly state the conditions of specific essential performance in the technical description of the Products.

Moisture Resistance (Clause 5.7)

The requirements for moisture resistance testing from IEC 60601-1 Edition 2.0 have been reinstated.

Documentation (Clause 7)

Many requirements related to documentation for instructions for use (IFU) and user manuals have been added. In addition, for all accompanying electronic documents, it has become mandatory to apply the usability engineering process described in the collateral standard IEC 60601-1-6 Usability when determining what information must be provided.

Marking and Labeling (Clause 7.2.2)

When printing labels on equipment and accessories, it has become mandatory to include a unique lot or batch identification number or serial number, expiration date, manufacturing date, and the manufacturer's contact information.

Electrical Hazards (Clause 8)

Numerous changes have been made regarding protection against the risk of electrical hazards, including defibrillator safety, creepage distance, protective earthing, and clearance. New limit values have been established for leakage current tests to verify proper installation connections. For equipment with appliance inlet sockets, testing of protective earthing with the power cord connected has become mandatory. For permanently installed equipment, a power lockout device is required if reconnection poses a risk of harm to the user.

Mechanical Hazards (Clause 9)

Mechanical hazard testing related to portable equipment and instability has been revised to include functional testing.

Temperature Tests (Clause 11)

Temperature limit values for applied parts have been clarified. Regarding overflow, equipment must be designed to always maintain essential performance and basic safety.

Construction (Clause 15)

For mechanical strength, the term "unacceptable risk" has been replaced with "basic safety and essential performance." Requirements for transformer construction have reverted to those of IEC 60601-1 Edition 2.0. For lithium batteries, compliance with IEC 60086-4 (for primary batteries) and IEC 62133 (for secondary batteries) has become mandatory.

What Is IEC 60601-1 Edition 3.1?

IEC 60601-1 Edition 3.1, published in 2012, addresses numerous issues identified as unclear or ambiguous in the original third edition published in 2005. Edition 3.1 includes nearly 500 changes and clarifications across a wide range of topics, including temperature testing, risk management, mechanical testing, essential performance, and moisture resistance testing. The revised Edition 3.1 also defines several new standards related to mechanical and electrical hazards.

What Is IEC 60601-1-2 Edition 4?

IEC 60601-1-2:2014 Edition 4 was issued in February 2014 as an update to Edition 3 of IEC 60601-1-2 published in 2007. It addresses EMC for medical electrical equipment and medical electrical systems.

The background to Edition 4 was the creation of safety standards related to electromagnetic disturbances in alignment with the general requirements of IEC 60601-1 Edition 3. Previous editions of IEC 60601-1-2 did not sufficiently address safety aspects related to electromagnetic interference. There are also significant differences in immunity requirements between Edition 3 and Edition 4.

The fundamental premise of IEC 60601-1 is the understanding and management of various risks. In Edition 3, this evolved through defining electrical performance requirements for safe operation from the perspective of protection for both patients and operators. These factors largely determined creepage and insulation specifications. It is also noted that Edition 3.1 clarified several previous definitions to accommodate advances in new technologies.

The EMC collateral standard in Edition 4 continues to focus on risk analysis but moves away from device categories such as "life-supporting" and instead gives full consideration to the "intended use environment." Specifically, it defines professional healthcare facilities, home healthcare environments, and "special" environments. Professional healthcare generally covers traditional use of medical devices in hospitals and similar locations with medical staff, which have seen increasing EMC challenges in recent years. Home healthcare covers both requirements for non-professional users and situations where the power supply may be unstable. "Special" environments refer to locations where very high levels of electromagnetic disturbances may occur, including industrial areas and radiation therapy rooms.

About UNIFIVE Emission and Immunity Testing

An overview of some requirements for emission and immunity testing in Edition 4 is provided below.

As explained above, Edition 4 defines three use environments for the Products: professional healthcare, home healthcare, and special environments.

In particular, use in special environments is addressed through the risk management process and may require the application of test levels or conditions different from those specified in Edition 4.

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

The maximum frequency for radiated immunity has increased from 2,500 MHz to 2,700 MHz, and a new "proximity" test has been added. Test levels have also been revised, and the modulation frequency is specified as 1 kHz only. The 2 Hz modulation frequency specified for certain devices in the previous edition is no longer specified in Edition 4.

UNIFIVE complies with these emission test definitions.

Wireless Functions in Medical Devices

When a wireless module is incorporated into a medical device, IEC/EN 60601-1-2 includes references to the use of wireless technology in medical equipment. If national requirements are met, exemptions from electromagnetic emission limits may be granted for the primary transmission signal; however, all other emissions must comply with the electromagnetic emission limits of IEC/EN 60601-1-2.

There are also many additional conditions and detailed test settings when medical devices include wireless functionality. In recent years, as IoT has become more prevalent in medical settings, this topic has attracted increasing attention.

This has been a brief chronological overview of medical standards related to medical power supplies. When selecting a power supply, choosing one that complies with medical standards can reduce the time required for complex safety testing. We offer a wide lineup and continue to develop medical power supplies daily to meet customer needs.

JIS Standards

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

Click here for more information about JIS standards

What Is IEC 60601-1-2 Edition 4.1?

IEC 60601 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 because it incorporates Amendment 1 to Edition 4.

The main changes are as follows:

Specification of Immunity Test Levels

In the new version, immunity test level specifications are defined according to the intended use environment. The use locations comply with IEC 60601-1-11 and are classified into professional healthcare environments, healthcare facility environments, home healthcare environments, and other special environments.

Establishment of Guidelines for Immunity Test Levels

Guidelines have been established for adjusting immunity test levels when special considerations apply regarding mitigation or intended use.

Test Levels for Portable RF Communication Equipment

Based on immunity test levels, tests and corresponding test levels have been defined to enhance the safety of medical electrical equipment and medical electrical systems when portable RF communication equipment is used closer than the recommended distances specified in Edition 3 of this standard.

Immunity Test Levels by Intended Use Environment

Immunity test levels have been specified according to the reasonably foreseeable maximum levels of electromagnetic disturbances in each intended use environment. As a result, some immunity test levels are higher than in the previous version. In addition, the term "life-supporting" has been removed from defined terms to better align with the concepts of basic safety and essential performance.

Risk Management for Electromagnetic Disturbances and Criteria for Immunity

Guidelines have been established for risk management related to electromagnetic disturbances affecting basic safety and essential performance, as well as for determining immunity pass/fail criteria.

Immunity Requirements by Port

Immunity tests and corresponding test levels have been specified according to the ports of medical electrical equipment and medical electrical systems.

Requirements for Special Environments

Guidelines have been established for determining immunity test levels in special environments.

IEC 60601 Edition 4.1 combines Edition 4 and Amendment 1 (AMD1:2020) into what is referred to as Edition 4.1.