F2 Labs Offering Assistance to Meet FDA’s Requirements for Wireless Electro-Medical Devices
F2 Labs is providing assistance in navigating the FDA’s requirements for wireless electro-medical devices. Its compliance experts can help you to determine what the FDA stipulates for Medical Devices that contain wireless transmitters, such as Bluetooth, BLE, Wi-Fi, RFID, or ZigBee.
Wireless coexistence testing to IEEE/ANSI C63.27 helps to close the gap left by IEC 60601-1-2 regarding wireless technology. The standard is used to determine if the product is affected by unintended signals being used in the same operating environment.
IEEE/ANSI C63.27 is an evaluation process and supporting test methods are used to quantify the ability of a wireless device to coexist with other wireless services in its intended radio frequency (RF) environments. The reliability of wireless communications that operate in the FCC unlicensed bands is a concern and could be susceptible to radiofrequency (RF) interference.
Below are the tiers for Coexistence per ANSI 63.27. The tier is determined based on the consequences of Functional Wireless Performance (FWP) Failure and is determined through a Risk Analysis (see AAMI TIR69 – “Risk management of radio-frequency wireless coexistence for medical devices and systems”)
Tier 1 – (Category A: MAJOR (High-Risk Level)) is the most thorough level of evaluation. It is intended for use where the consequences of unacceptable performance are most severe or where the highest levels of evaluation certainty are required.
- A more rigorous set of unintended test signals and scenarios are used in the evaluation.
- The potential for interfering signals in adjacent bands is more rigorously evaluated.
Tier 2 – (Category B: MODERATE (Medium-Risk Level)) is a more thorough level of testing than Tier 3
- The number of unintended test signals used is increased (from Tier 3) to extend the evaluation sample set and increase the confidence level of the evaluation outcome.
- The potential for interfering transmission in some adjacent bands is evaluated.
Tier 3 – (Category C: MINOR (Low-Risk Level)) is a selection of test cases to give the greatest confidence in the evaluation for the minimum amount of testing.
- The number of unintended test signals that the EUT is exposed to is limited to the minimum set, selected to provide the greatest insight to the EUT coexistence capabilities for the most limited amount of testing.
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