Interconnection


Beyond IEC 6061-1-3.2 – what next for medical equipment?


Nick Harper, managing director at ODU-UK Ltd, takes a look at the next edition of the core standard for the safety of medical electrical equipment


T


he current Edition 3.2 of IEC 60601-1 was published in August 2020 and planning for a fourth edition (1)


was


launched in April 2025, with the intention of producing a final version in April 2030, followed by a two-to-three-year implementation phase.


IEC 60601 sets out the basic requirements for electrical medical devices and systems, published by the International Electrotechnical Commission. First published in 1977 with a second edition in 1988 and a third edition in 2005, each with regular updates, the current version IEC 60601- 1-3.2, published in August 2020, covers healthcare devices, such as: 1 Medical electrical equipment (MEE) includes equipment such as electrocardiograms (ECGs), ultrasound machines, X-ray machines, infusion pumps, and defibrillators.


2 Medical electrical systems (MES) a combination of equipment, which may also include certain non-medical electrical equipment, which are interconnected.


3 Medical software: this category includes software applications and systems used in medical devices, such as patient monitoring, diagnostics and electronic medical records. EN 60601 is a matrix series of standards which contains both collateral (60601-1-X) and particular (60601-2-X) standards. The collateral standards (currently 10) provide additional material that is not in the main standard document and covers all device types where applicable. Particular standards (currently 80) are applied to specific devices within the scope of the standard. It is highly likely that a single device can be subjected to the requirements for several standards depending on the application and intended use. Compliance with these standards is usually a legal requirement for manufacturers selling medical devices in many countries and there is a direct read-


28 February 2026


across into both MDR in Europe and FDA requirements in the U.S.


So, can we ignore the fourth edition for the next few years? Well, not really. Now might be the time to examine existing designs, even if they are currently compliant, to consider the potential effect of tightened performance standards. Of course, any new projects must now assume that they will fall under the likely tightened performance requirements of the fourth edition.


So, what will be in the fourth edition?


Obviously, we don’t know any detail yet, but the tasks of the various working groups now involved in draughting the fourth edition gives some clues (see text box above right).


Experience from existing editions IEC 60601 is a complex document of interlocking and overlapping


Components in Electronics


requirements, covering thousands of pages, which can be a daunting read. Smaller OEMs undoubtably needed to seek expert advice from third-parties. Some OEM’s encountered difficulties with implementation and were late to call on the expertise of their suppliers, who can


Working Group 37 Revised Use Specification Working Group 38


Revised Environmental Conditions & Test Revised Ingress Protection Additional Battery Management Working Group 39


Revised Legibility Requirements Revised User Interface


Additional Indication & Controls Working Group 40


Revised Sterilization Standards Working Group 41


New Software and EDI Controls Working Group 42


Revised Insulation & Reduced Spacing Revised Earthing


New Production-Line Testing Working Group 43 Revised Mechanical Hazards Working Group 44 Revised Fire Protection Working Group 45 Revised Optical Radiation Working Group 46 Revised Ionization Radiation Working Group 47


Electromagnetic Exposure Hazards Working Group 48 Electromagnetic Disturbance


often provide solutions to help with issues, such as shielding. In our case, the third edition of IEC 60601-1 gave rise to two very specific products:


ODU MEDI-SNAP connectors Devices operating in an electromagnetically


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