What Is IEC 60601-1?

IEC 60601-1 is the international safety standard for medical electrical equipment, published by the International Electrotechnical Commission. Its full title refers to general requirements for basic safety and essential performance. Basic safety means protection from hazards such as electric shock, excessive leakage current, overheating, fire and moving parts. Essential performance means the clinical functions that must keep working, or fail safely, for the patient to be safe.

The standard applies to equipment that diagnoses, treats or monitors a patient and has an electrical connection, from infusion pumps and patient monitors to surgical displays and cart-mounted computers. It also covers medical electrical systems, where several devices, some of them ordinary IT equipment, are combined into one installation.

EN 60601-1 is the European adoption of the same standard, harmonised under the EU Medical Device Regulation. In the US it is published as ANSI/AAMI ES60601-1, and in Canada as CSA C22.2 No. 60601-1. The current edition is the third, published in 2005 and amended in 2012 and 2020.

IEC 60601-1 is a long document, but most of its requirements fall into a handful of areas.

Leakage current is the small current that flows from mains-powered equipment through insulation, earth or a person. The limits depend on the path and on the type of applied part, the part that touches the patient. NC is normal condition and SFC is single fault condition.

Type B parts are not isolated from earth, Type BF parts are floating, and Type CF parts are floating and suitable for direct contact with the heart. A device’s label shows its applied part type with a symbol of a figure, a figure in a box or a heart.

The standard matters most near the patient. Equipment within the patient environment, the space around a patient where contact is possible, has to meet IEC 60601-1 itself or be combined with other equipment into a compliant medical electrical system, for example by using isolation or a medical grade power supply. The patient environment is usually taken as 1.5 m around the patient and up to 2.5 m above the floor.

Clause 16 of the standard covers medical electrical systems. A cart or workstation is assessed as a whole, not just its parts, so a computer, display, capture card and isolation transformer must together meet the leakage and protection limits. Our guide to the medical grade power supply explains how isolation is usually achieved.

IEC 60601-1 is the general standard. It sits at the top of a family of related documents that add requirements for specific risks or specific devices.

In the United States, IEC 60601-1 is adopted as ANSI/AAMI ES60601-1, published by the Association for the Advancement of Medical Instrumentation. It carries the IEC text with US national differences, mainly for mains wiring, plugs and markings that suit the US electrical system, and the FDA recognises it as a consensus standard for device submissions. Canada uses the equivalent CSA C22.2 No. 60601-1.

UL 60601-1 was the earlier US version, based on the second edition of IEC 60601-1. It was withdrawn when the US moved to the third edition, with the FDA transition ending around 2013, so new equipment is assessed to ES60601-1 instead. The name lives on because test houses such as UL Solutions, Intertek and CSA Group certify equipment to ES60601-1, and datasheets often shorten that to “UL 60601-1”.

For equipment sold on both sides of the Atlantic, the usual route is one CB test report to IEC 60601-1 that also covers the US and Canadian national differences, rather than separate test programmes for each market.

Most computers and monitors used in hospitals are not medical devices themselves, but they often sit in the patient environment or connect to devices that are. A medical-grade computer or display built to IEC 60601-1 removes the need for extra isolation and makes the system assessment simpler. A standard office PC can still be used in some places, but usually only outside the patient environment or behind an isolation transformer.

When specifying, ask for the certificate and the CB test report, check which edition and amendments it covers, and confirm the IEC 60601-1-2 EMC test level. The medical cart computer case study used EN 60601-1 certified hardware, and our explainer on the medical cart covers how those systems are built.

Our medical grade monitors and medical panel PCs are built to IEC 60601-1, and we have supplied them across medical and pharmaceutical projects. We integrate and validate each medical system as standard, with the isolation and power chosen for where it will sit.