F2 Labs performs FDA-required EMC testing for immunity to common electromagnetic and RF emitters as part of the 510(k) medical device approval process. Our testing ensures your device functions safely and reliably in real-world electromagnetic environments.
Common EM emitters and 5G Testing
The FDA has been requiring Immunity testing to Common EM emitters and 5G cellular per their “Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff” guidance document. We have been testing for Immunity to Electrosurgical Devices, Diathermy Devices, EAS and Metal Detectors, and recently WPT (Wireless Power Transfer) devices, and NFC (Near Field Communication) Emitters for years. The FDA has now added immunity to 5G cellular FR1 and FR2, including mmWave bands that are not being used in many areas yet, so the task of showing Immunity to these bands is not as simple as placing some 5G cell phones near the device. Because there are currently no standards written that cover these tests, F2 Labs developed testing so that products can show compliance with Immunity to Other Sources of EM Emitters / RF Emitters including Electrosurgical Devices, Diathermy Devices, X-ray device, EAS and Metal Detectors, WPT (Wireless Power Transfer) devices, NFC (Near Field Communication) Emitters, and 5G cellular signals in both FR1 and FR2 bands. Our customer’s test reports have been submitted with their 510k files, and these test reports with our test methods have been accepted by the FDA for their products.
Contact F2 Labs experts to discuss how to meet the FDA’s requirements per “Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff”. We’ve worked directly with the FDA to develop testing so products can show compliance with Immunity to Other Sources of EM Emitters / RF Emitters including Electrosurgical Devices, Diathermy Devices, EAS and Metal Detectors, WPT (Wireless Power Transfer) devices, NFC (Near Field Communication) Emitters, 5G cellular signals in both FR1 and FR1 including mmWave bands.
Electromagnetic compatibility (EMC) testing is required by the FDA for nearly all medical devices. EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment. This includes immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances or emissions that might interfere with other devices.
AIM 7351731 specifically applies to medical electrical equipment and systems to make sure that RFID Readers in the area do not affect the device’s operation. In addition to AIM 7351731, the FDA almost always also requires testing to ensure other types of devices won’t interfere with a product’s function. Here are some examples of known disturbances the FDA requires products to be evaluated with:
- Metal Detectors
- Electronic Article Surveillance (EAS)
- Electrosurgical
- Diathermy
- Ultra-sound
- X-ray devices.
The FDA has developed a document to describe relevant information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. In this document and relevant standards, the FDA outlines what degree of detail about your product they require for a premarket submission. This submission should include:
- the environment as defined by the manufacturer;
- a summary of testing performed;
- what specifications of each standard were met;
- functions of the device tested;
- details of the performance of the device;
- identification and justification for any deviation from specifications of standards met;
- device labeling;
- description of all changes and modifications made to the device post-testing;
- and more.
This being said, the FDA is also free to request additional information depending on the use and intended use environment of a specific active medical device to demonstrate EMC. This request typically comes from the FDA reviewer who sends feedback to manufacturers and says something akin to the statement below:
| “IEC 60601-1-2 standard generally does not adequately address EMC for several common RF emitters. Please specifically address exposure to known sources of EMI with medical devices such as diathermy, electrosurgical, X-ray, RFID, security systems (e.g. anti-theft systems, metal detectors). Please note some of these RF emitters (e.g. RFID) may not be visible and the device can potentially be exposed to fields from these RF emitters without the user’s awareness.” |
F2 Labs is prepared to help you determine and define all of these requirements for FDA approval in order to make your testing experience as smooth as possible. Contact us today for more information.
Helpful Links:
FAQs
How do I configure my device for Common EM Emitters testing?
Your device should be set up to operate as it would under normal operating conditions. Typically, it would be set up the same as it would be for 60601-1-2 testing.
What modes should be tested for Common EM Emitters testing?
It is up to the client to determine what mode(s) should be tested for Common EM Emitters testing. Essentially, the Common EM Emitters testing is just adding in other types of immunity testing. We recommend that you test in the same mode(s) as you would for 60601-1-2 testing. For example, AC mains while charging mode, Battery only mode, Standby, Operating, etc.
How is pass/fail determined for Common EM Emitters testing?
Since there is no formal standard, you will determine pass/fail (what is acceptable). Typically, we see the same pass/fail and EP being applied as what would be chosen for the 60601-1-2 testing. For example, is it acceptable for the device screen to glitch, is it unacceptable for the device to turn off, etc.
Is there a standard for Common EM Emitters testing?
There is no set standard for this, nor is a test method called out in the FDA guidance. The FDA has and is currently accepting our reports and we perform this testing weekly for clients.
Can you describe how the Common EM Emitters testing is performed?
Your device will be subjected to the particular Common EM Emitter from a very close range. If your device is affected negatively (does not meet your declared pass/fail criteria or EP), we will continue moving the emitter back until it is no longer negatively affected. The distance would be recorded, and you would put this into your documentation/warnings. In your Risk File, this would become your risk mitigation.
Does the FDA accept our Common EM Emitters report?
Do I need to supply a Test Plan to F2 for Common EM Emitters testing?
You may do so, but we do not need it. We will collect the information we need to determine our test plan, which ultimately becomes part of the test report. We will only need to know how the equipment will be set up, what your Pass/Fail criteria will be, and what modes are to be tested.
What happens if the Common EM Emitters testing negatively affects the support/measurement equipment? (for example, a device used to measure EP, a test lung to simulate breathing, etc.)?
We do not see this happening during testing because we are able to ‘focus’ the interference on the device under test. If your support equipment was to be negatively affected, we would work to address it. How we do that would depend on how the interference is getting to the support equipment.
Can F2 share specifics/details of the Common EM Emitters testing? (frequencies, modulations, other)
No – we consider this information to be proprietary.
If F2 cannot share the specifics/details of the Common EM Emitters testing, how will I be able to prepare my Test Plan and Risk mitigation documentation?
We do not require a Test Plan. We will collect the information we need to determine the test plan, which ultimately becomes part of the test report. If you do prepare a Test Plan, we recommend that you keep it simple – we will only need to know how the equipment will be set up, what your Pass/Fail criteria will be, and what modes are to be tested. The Risk mitigation cannot take place until after you have the results of the testing – it will become the safe distance warnings in your Documentation.
Since my product will never be subjected to anything on the list for Common EM Emitters, do I still need to do this testing?
Common EM Emitters testing should still be considered because the FDA has required it on devices in the past. Even prior to use, they have stated that it is likely that a device would be subjected to these phenomena during shipping/other transport, and they want to ensure that it arrives working as intended and safely. It is difficult (if not impossible) to know these days everywhere these technologies are being used, and the use of these technologies is increasingly common. Our pricing does not change if any items are removed from the list for testing – so we recommend completing all of the testing.
We submitted a pre-sub to the FDA, and they have asked us to provide a Test Plan with the frequencies and levels we intend to use for Common EM Emitters testing. What are we supposed to provide to them?
You should tell the FDA that the frequencies and levels are to be chosen by F2 Labs who have done this testing many times. F2 Labs has had many customers submit these reports to the FDA and they have been accepted by the FDA. F2 Labs will perform the Common Emitters testing in a chamber using a Radiated Field Method, with the test equipment required to generate the necessary fields and waveforms. They will expose all sides of the product to the interference source one side at a time, to ensure all sides and areas of the product get exposed to interference source to observe if any degradations occur.
