Standards · Standard or regulation
IEC 60601-1-2
Medical electrical equipment, Part 1-2: Electromagnetic disturbances, requirements and tests
In plain words
What it covers.
The collateral standard for electromagnetic compatibility (EMC). It sets how much electromagnetic energy a medical device may give off, and how much interference it must survive without losing basic safety or essential performance. Test levels depend on where the device will be used: professional healthcare facilities, home healthcare or special environments such as near MRI.
Who uses it: Manufacturers and EMC test labs; clinical engineers investigating interference, planning device co-location and building layouts near MRI or radio sources.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Emission limits
- Immunity to radiated RF fields
- Immunity to electrostatic discharge, fast transients and surges
- Immunity to wireless devices close by
- Use environments and test levels
- Labelling and separation distances
Key points
What engineers need to know.
- Devices must both limit their own emissions and tolerate interference from others.
- Radiated immunity is typically tested at 3 V/m in professional healthcare and 10 V/m for home use.
- Close-range tests check immunity to phones and radios held near the device.
- Immunity is judged against essential performance: the device must keep doing its safety-critical job.
- Special environments such as MRI suites and heavy industrial supplies may exceed the tested levels.
- Manufacturers must state the intended EMC environment in the instructions for use.
- A device that passes still has limits: field strength near strong sources can exceed test levels.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
- ECMOPlatform course
- VentilatorPlatform course
- EP Mapping SystemPlatform course
- Cranial DrillPlatform course
- EndoscopePlatform course
- Cardiac MonitorPlatform course
- DEXA ScannerPlatform course
- Infant IncubatorPlatform course
- Blood Pressure MonitorPlatform course
- NebulizerPlatform course
- LaryngoscopePlatform course
- StethoscopePlatform course
Medical City
Where you practise it.
- Story Three electromagnetic investigation (S3-M052, S3-M053) and MRI suite case (S3-M182 to S3-M185)
- Tech Detective interference cases
- S1-M024 lift motor interference