Have you ever worked with a medical device that requires Wi-Fi access to operate only for it to start acting funny? Your phone seems to be connected to the internet, so what exactly has gone wrong?
The likely culprit is electromagnetic interference. It isn’t uncommon for medical equipment to start acting haywire in the medical industry, but this can become a huge problem if the medical device’s operating correctly can mean the difference between your patient’s life and death.
This is where EMC testing comes in.
Also known as electromagnetic compatibility, EMC testing takes a preemptive approach by preventing these kinds of interferences from happening in the first place.
Here is a brief guide to how EMC testing works and why it’s important.
Interference, Interference, Interference
That’s right. Electromagnetic interference is everywhere in the modern world. Whether you have a high-tech computer or an old flip-phone, all electronic devices produce some electromagnetic frequency.
This can account for an unintentional magnetic signal that may interfere with the performance of other electronic devices.
All electronic products must undergo a period of EMC testing, but the EMC requirements for medical devices are the most heavily regulated.
EMC Requirements In the Medical Industry
When crucial medical equipment is not properly tested, electromagnetic interference can have a detrimental effect on the patient’s ability to get therapeutic benefits.
This can result in needless injuries, lawsuits, or even fatalities.
Manufacturers must understand their product can be affected by being near other electronic devices to get the safest and most efficient use of these medical devices.
EMC testing identifies the source of possible interferences as they pertain to the device’s design.
Risk Management During EMC Testing
The test house will provide a 360-degree assessment and analysis of the device while it is turned on.
They will:
- Check the amount of radiation the device gives off
- Isolate radiation-heavy circuits and/or components
- conduct the test in an anechoic antenna chamber
- Dampen secondary reflections off chamber surfaces
- Consider international transmissions
- Ensure the product operates at the right frequency
- Ensure the product operates at the right power level
The international agencies making the final determinations of the medical equipment’s EMC compliance are:
- FCC (US)
- ISED (Canada)
- Radio Equipment Directive (Europe)
Regarding wireless use, the performance of medical devices must not be negatively affected by the wireless link.
If the device is wirelessly compatible but doesn’t communicate, the test house would determine this product failed in terms of functionality.
Since more medical sectors are transitioning to wireless, the radio spectrum has taken a congestive hit. Some of these wireless functions include:
- Bluetooth
- Wi-Fi
- ZigBee
- ANT+
Since the probability of interference has increased due to this wireless transition, federal government agencies have placed higher regulations on the medical device industry.
Mitigating EMC Failures of Wireless Devices
In normal circumstances, losing Wi-Fi on our smartphones is a minor inconvenience.
When your iPhone needs Wi-Fi access to assist in critical medical evaluations, EM interferences can be life-threatening to the patient. This rings especially true for remote alarms relying on Wi-Fi connections as they pertain to:
- Possible IV drug failures
- Critical signs
Proper EMC testing is vital to medical devices’ functionality because it can mitigate the chances of these failures happening in the healthcare industry.
EMC testing labs perform test after test to ensure these functions remain active in the newly crowded wireless healthcare world.
Did You Find This Information Useful?
Navigating through a congested environment is no easy task, and the growing regulations for medical devices as wireless compatibility takes the world by storm proves this.
We hope this article demonstrated how vital EMC testing has become as the medical industry grows more technologically advanced.
