F2 Labs offers AIM 7351731 testing to verify the compatibility and performance of RFID systems used in healthcare environments. We help ensure your devices meet FDA-recognized standards for safe and effective operation around medical equipment.
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 safety testing laboratory 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.
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FAQs
Is AIM 7351731 a requirement for the FDA?
For RFID Immunity testing the FDA refers manufacturers to IEC 60601-1-2 Table 11 or AIM 7351731. We typically recommend completing AIM 7351731 in addition to the 60601-1-2 Table 11 testing because it is much more extensive/inclusive and better represents the actual RFID threats that exist (frequencies/modulations).
If our device is only intended for use in a surgical operating room, does this eliminate the need for testing to 60601-1-2 Table 11?
No – testing to Table 11 of IEC 60601-1-2 is still required. Table 11 outlines requirements specific to different healthcare environments. While the 30 kHz frequency is only applicable to medical equipment (ME) used in home healthcare settings (as indicated by the “a.)” symbol next to that frequency in Table 11), the other two frequencies—134.2 kHz and 13.56 MHz—are still required for all ME equipment, including devices used in professional healthcare settings, such as surgical operating rooms.
In short, devices intended for professional healthcare environments (like surgical settings) are not required to test the 30 kHz frequency, but the 134.2 kHz and 13.56 MHz frequencies must still be tested. We work closely with the FDA and are familiar with their expectations, so we can confirm that they specifically look for this table to be completed as part of the regulatory process.
Why should a customer test to AIM 7351731 in addition to IEC 60601-1-2:2020 (including Table 11)?
The IEC 60601-1-2:2020 (Ed. 4.1) standard includes a new table, Table 11, which outlines the requirements for testing Radio Frequency Identification (RFID) immunity. Table 11 is required for all medical devices, both battery operated and AC mains (&while charging).
The AIM 7351731 standard includes testing at all the RFID frequencies and test levels specified in its Table 3, whereas IEC 60601-1-2:2020 Table 11 only looks at 3 frequencies.
This means that the frequencies tested under the IEC 60601-1-2:2020 Table 11 are a subset of those tested under the AIM 7351731 standard. The exact frequencies would depend on the specific device and its intended use.
