AIM 7351731 Testing
F2 Labs is proud to be a global leader in AIM 7351731 compliance testing. In fact, F2 was the very first lab worldwide able to offer its customers testing to these standards. Many of our customers have learned about F2 through the FDA itself, as the agency is familiar with F2’s expertise in this area.
AIM 7351731 testing is now strictly required by the FDA and specifically applies to medical electrical equipment and systems. AIM 7351731 sets forth test methods/levels for (1) the electromagnetic immunity of such equipment/systems, and (2) electromagnetic emissions from radio-frequency-identification (RFID) readers that are including in such equipment/systems.
It is important to note that AIM 7351731 is applicable to all electrical medical devices, not just medical devices that contain wireless devices/components. Reach out to us with any questions that you might have about the impact of AIM 7351731 on your device.
More about AIM:
This AIM Standard does not consider other technologies such as Wi-Fi and ultra-wideband (UWB). It focuses on the most common RFID technologies currently deployed in healthcare environments.
AIM 7351731 also provides guidance to RFID solutions whether you’re a designer, medical facility engineer or administrator. AIM 7351731 can help you to determine whether the medical electrical equipment/device or medical electrical system, and the RFID solution environment, are compatible.
We can perform the testing required by AIM 7351731 and provide you with the test reports that you would submit to the FDA for your medical device approval. Contact F2 Labs today for more information.
AIM 7351731 – Medical Electrical Equipment & System Electromagnetic Immunity Test for Exposure to RFID Readers, is an FDA Recognized Consensus Standard.
- Recognized Consensus Standards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm
- Wireless Medical Devices https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices#8