BS EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect equipment and prevent it from working in the way it was intended to. So it is essential that medical equipment is not oversensitive to radio frequency interference. Likewise, electromagnetic emissions from a medical device shouldn’t interfere with other equipment and systems.
The fourth edition of BS EN 60601-1-2, published in 2015, specifies immunity test levels 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 updated standard recognises that phones and other radio frequency devices can no longer be prohibited from most patient environments, as in many cases they have become essential to efficient healthcare provision – so specification of test levels assumes that portable radio frequency equipment may be used closer to the medical equipment than was recommended in the last edition. The standard specifies levels based on a reasonably foreseeable maximum level of electromagnetic disturbances.
The new edition also includes additional guidance on:
- Adjusting test levels for special environments and under special circumstances
- Incorporating electromagnetic disturbances into the risk management process.
- Identifying pass/fail criteria
BS EN 60601-1-2:2015 will be essential reading for all manufacturers and users of medical electrical equipment.