It’s critical that medical electrical equipment performs as intended and safely. To these ends, we’ve amended one of the core European standards in this area. This blog post explains what the standard covers and what’s been changed by the amendments.
BS EN 60601-1 consists of requirements, definitions, test specifications, and informative material. It comprises seventeen clauses with subclauses over more than 420 pages and can also be applied to equipment used for compensation or alleviation of disease, injury, or disability.
BS EN 60601-1-2:2015+A1:2021 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests is one of the collateral standards that add requirements to the general standard.
With the proliferation of wireless and mobile technology, electromagnetic disturbances arise that can affect equipment and prevent it from working as intended. It’s consequently essential that medical equipment is not oversensitive to radio frequency interference.
Likewise, medical devices themselves shouldn’t produce electromagnetic emissions that could potentially interfere with other equipment and systems. Therefore BS EN 60601-1-2 specifies requirements and tests for the safety of medical electrical equipment and systems. It covers equipment for use in professional healthcare facilities or the home, where different test levels may be appropriate.
The standard is more than 100 pages long and over nine clauses cover general requirements; medical electrical equipment and systems identification, marking and documents; test documentation; electromagnetic emission requirements; electromagnetic immunity requirements; and test reports.
Amendments to the standard
This standard is for use by medical device manufacturers, users of medical devices, and regulatory bodies. It will also be of interest to suppliers of medical electronic equipment and components, as well as to healthcare facilities and hospitals.
When the preceding version of this standard was used by manufacturers and regulators, we received feedback that inconsistencies had been found. These were found in measurement units, testing requirements, and regionality in the application of the standards.
The relevant committee reviewed the anecdotal feedback and concluded that the issues were significant enough to warrant amendments being produced ahead of a planned full technical revision, scheduled to be published in 2024.
Consequently, amendments have been made to BS EN 60601-1-2:2015+A1:2020 to streamline testing requirements and units of measurement to improve the standard’s practical implementation. These amendments are intended to improve the usability of this important medical electrical equipment safety standard.