FDA AIM 7351731 – Immunity for Wireless device
January 16, 2024
If you are a medical device manufacturer, you may be aware of the importance of ensuring that your products are immune to radio frequency (RF) interference from radio frequency identification (RFID) readers and other sources. RF interference can cause malfunction, degradation, or damage to medical devices, which can compromise patient safety and quality of care.
The Food and Drug Administration(FDA) requires medical device manufacturers to demonstrate immunity to RF interference as part of the premarket approval process. One of the standards that the FDA references for this purpose is AIM 7351731, which covers the testing of medical electrical equipment and systems against RFID readers. This FDA-recognized standard addresses a range of common RFID technologies used in healthcare settings, such as passive and active tags, low-frequency (LF), high-frequency (HF), and ultra-high-frequency (UHF) systems.
However, AIM 7351731 testing scope does not address other RF sources that may be present in the same environment as medical devices, such as Wi-Fi, ultra-wideband (UWB), 5G cellular, wireless power transfer (WPT), near-field communication (NFC), metal detectors, electronic article surveillance (EAS), electrosurgical cut/coagulate, diathermy, and X-ray. These sources can also generate RF interference that can affect medical devices.
To address this gap, the FDA has recently issued a new guidance document that expands the scope of RF immunity testing beyond RFID readers to include other RF emitters. The document recommends how to select the appropriate RF emitters for testing based on the intended use environment of the medical device. For example, devices used in home, doctor's office, or sleep lab settings may not require testing against all RF emitters. On the other hand, devices used in diverse settings like operating rooms or emergency departments may require more rigorous testing.
For implanted devices, the FDA recommends testing against all RF emitters, regardless of the use environment, because of the potential exposure scenarios. An implanted device may encounter a metal detector at an airport security checkpoint, or a WPT device at a charging station. Therefore, it is essential to ensure that implanted devices are immune to all possible RF interference sources.
As a medical device manufacturer, you should follow the FDA guidance document and the AIM 7351731 standard to ensure that your products are immune to RF interference from RFID readers and other RF emitters. This will help you comply with the regulatory requirements and ensure the safety and performance of your devices in various use environments.
Are you looking for guidance on how to comply with the latest regulations in your industry? Do you need assistance with the documentation and certification process? If so, you can rely on 360Compliance experts to help you out! We have the experience and expertise to provide you with the best solutions for your compliance needs. We offer comprehensive consulting, training, and certification services tailored to meet AIM 7351731 compliance testing standards. Our expert team is dedicated to guiding you through the intricacies of FDA approval, ensuring that your medical devices not only meet the latest EMC requirements but also adhere to the specific criteria outlined in AIM 735173. Contact us today and let us know how we can help you achieve your compliance goals!
Other Sources of electromagnetic (EMC) Immunity
Immunity to specific RF emitters that are known sources of electromagnetic disturbances:
Electronic Article Surveillance system (EAS)
WPT (Wireless Power Transfer)
5G Cellular emitters (in both FR1 and FR2 using equipment to generate the frequencies, modulations, and power
of 5G cellular including mmWave technology)
This requirement is per FDA Guidance Document - Electromagnetic Compatibility (EMC) of Medical Devices June 6, 2022