IEEE 2725.1-2024

New IEEE Standard - Active.

Requirements and guidelines for the design of radiofrequency (RF) brain imaging systems, to help protect subjects/users/patients from adverse effects from overexposure to RF electromagnetic energy, and from other electrical, mechanical, chemical, and biological hazards are specified by this standard.

This standard is limited to brain imaging devices using a brain machine interface (BMI) that intentionally couples low-level RF electromagnetic energy, in the frequency range between 10 MHz and 20 GHz, into the human head using antennas or probes in direct contact with, or close proximity to, the human head.

This standard pertains to brain imaging and brain machine interface (BMI) devices that intentionally couple low-level radiofrequency (RF) electromagnetic energy (EME), in the frequency range between 10 MHz and 20 GHz, into the human head using antennas or probes in direct contact with, or in close proximity to, the human head.

This standard specifies requirements and guidelines for the design of such devices to help protect operators, users, and patients from adverse effects from overexposure to RF EME and from other electrical, mechanical, chemical, and biological hazards.

This standard does not cover requirements on Electromagnetic Compatibility (EMC), but it contains safety provisions that assist in preventing the device from producing excessive transmit power as could, for example, occur in the event the device’s operation is compromised due to external RF interference.

The safety provisions include the requirement for an independent watchdog circuit on every antenna channel to cause it to safely shut down in the case excessive transmit power is detected during operation.

The purpose of this standard is as follows:

• To specify the maximum allowable exposure of RF EME to which the device may expose the human head, and how to evaluate compliance with the relevant exposure limits.
• To specify the required means within the device to continually monitor the device energy emission, to automatically deactivate the device, and alert the operator and the user in the event the exposure limits might be exceeded.
• To specify electrical safety requirements to help ensure that, during normal operation, or in the event of any single-point hardware, firmware, or software failure, the device does not expose the user to RF EME or leakage currents exceeding relevant exposure or safety limits.
• To specify mechanical, chemical, and biohazard safety requirements.