EMC
Medical electrical equipment and systems are expected to provide basic levels of safety and performance without interfering with other devices. This means that manufacturers must provide evidence for a device’s Electromagnetic Compatibility (EMC) and resistance to Electromagnetic Interference (EMI).
At Test Labs, we can help you through this complex process, from constructing a relevant EMC test plan to full certification.
Frequently Asked Questions
What is EMC testing for medical devices?
Electromagnetic compatibility (EMC) tesing is necessary for nearly all electrical devces, but the requirements for medical electrical devices are much more strict in comparison to consumer-grade devices, due to the higher risks involved. The testing determines whether or not a device will produce enough electromagnetic interference to cause malfunctions in other devices, as well as whether the device itself is susceptible to interference from other devices.
When should EMC testing be performed?
IEC 60601-1-2 is a crucial part of the IEC 60601 series of standards. Electromagnetic Compatibility and Electromagnetic Interference should both be considered in the early stages of development, as retesting and changes to late-stage designs are both expensive and time consuming.
Are the requirements different for medical devices used in shielded locations?
Yes, medical devices that are specifically for use in shielded locations must undergo different methods with different criteria to more standard equipment. Guidance for this can be found in Annex E of the standard. Contact Test Labs for support in building a suitable test plan for this kind of equipment.
The requirements of IEC 60601-1-2 don't make sense for my device, what standard should I apply?
It is likely that there is a “particular” standard in the IEC 60601-2 series that has amended requirements for your device. Test Labs can help you construct a relevant test plan for your device based on these particular standards.