Immunity to RFID Readers testing is required by the FDA for medical devices. The most common standard used for Immunity to RFID Readers testing is AIM 7351731. AIM 7351731 specifically applies to medical electrical equipment and systems.
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 and other environments where RFID Readers may be used but never seen.
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.
AIM 7351731 – Medical Electrical Equipment & System Electromagnetic Immunity Test for Exposure to RFID Readers, is an FDA Recognized Consensus Standard. 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 accredited testing to these standards. The FDA itself refers companies to F2 Labs for AIM 7351731 testing.
AIM 7351731 sets forth test methods/levels for the different RFID technologies used on the market today.
It is impossible to know everywhere that RFID readers are used, and therefore the FDA requires this testing to ensure the product will not be interfered with and operate correctly.
It is important to note that AIM 7351731 applies to all electrical medical devices, not just medical devices that contain wireless devices/components.
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.