What is BS EN 60601-1-2:2015/A1:2021 about?
This is the second “Part 1” standard in an extensive series of European standards on medical electrical equipment safety. As a “collateral standard” – it sets out requirements that are in addition to those in the general standard BS EN 60601-1.
BS EN 60601-1-2:2015+A1:2021 covers basic safety and essential performance for all medical electrical equipment in relation to electromagnetic disturbances.
Who is BS EN 60601-1-2:2015+A1:2021 for?
- Manufacturers and users of medical equipment
- Suppliers of medical electronic equipment and components
- All healthcare facilities/hospitals/intensive care units
- Health and safety professionals
- Regulatory bodies
Why should you use BS EN 60601-1-2:2015+A1:2021?
This is a collateral standard in the series covering basic safety and essential performance for both medical electrical equipment and systems.
With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect equipment and prevent it from working in the intended way. It’s 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.
Therefore BS EN 60601-1-2:2015+A1:2021 applies to the basic safety and essential performance of ME equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by ME equipment and ME systems. It specifies immunity test levels for the safety of medical electrical equipment and systems and covers equipment for use in professional healthcare facilities or the home, where different test levels may be appropriate.
What’s new about BS EN 60601-1-2:2015+A1:2021?
This amendment tackles streamlining of testing requirements and units of measurements to improve the standard’s practical implementation.