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Medical Equipment Update: EN 60601-1-2:2015 +A1:2021 (IEC 60601-1-2 Edition 4.1)

*Significant technical changes mean manufacturers should review their products now*

EN 60601-1-2:2015 +A1:2021, the European standard on electromagnetic disturbances to medical electrical equipment and systems, has been amended to streamline its testing requirements and units of measurements and to make the implementation of the standard easier.

Covers safety and essential performance for all medical electrical equipment in relation to electromagnetic disturbances

The update includes significant technical changes with respect to the previous edition and is relevant to any manufacturers, suppliers, and users of medical electrical equipment and components.

As a collateral standard, it sets out requirements that are in addition to those in the general standard BS EN 60601-1 and covers basic safety and essential performance for all medical electrical equipment in relation to electromagnetic disturbances. 

Covers equipment for use in professional healthcare facilities or the home

The standard is essential in ensuring that medical equipment isn’t susceptible to radio frequency interference and that any electromagnetic emissions from a medical device will not interfere with other equipment and systems. This includes the specification of immunity test levels and covers equipment for use in professional healthcare facilities or the home, where different test levels may be appropriate.

Introduces new proximity to magnetic field test

One of the key technical changes includes the addition of a new proximity to magnetic field test, with test frequencies at 30 kHz, 134.5 kHz & 13.56 MHz as per EN 61000-4-39. Manufacturers need to evaluate if this completely new test, which hasn’t been required before, is now applicable to their product. 

Manufacturers should undertake a review of their products now

Element advises that all manufacturers should undertake a review of their products now, including a full risk management process if the product contains any magnetically susceptible devices. 

Other technical changes of note include:

  • the removal of the direct requirement to consider the aircraft environment
  • conducted emission and voltage dips to be carried out at minimum and maximum rated voltage, unless the difference between the maximum and the minimum rated input voltage is less than 25 %
  • conducted immunity now applicable to SIP/SOP on cables greater than 1m.

This latest edition of the standard also includes new guidance on testing permanently installed / large systems and a revision of the guidance on the application of risk management with regard to electromagnetic disturbances. The transition period will come to an end on 19 March 2024 and all products must fully comply, at the latest, by this date. 

For more information on EN 60601-1-2:2015 +A1:2021, or to learn more about Element’s testing and validation services for medical equipment and systems, please contact us to speak to one of our Medical Regulatory Affairs and Safety Testing experts.

 

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