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Publication Number: 617965 Rule Parts:  Publication Date: 12/08/2017
Keyword: Part 95 MedRadio, Human Torso Simulator, Tissue-equivalent Material and Testing Requirements

First Category: RF Exposure *
Second Category: General (RF Exposure)

Question:   Is it acceptable to use the torso simulator and tissue-equivalent material previously specified in Part 95 rules for testing of MedRadio transmitters in cardiac pacemaker and defibrillator implants?



Answer:  

Testing of transmitters used for medical implant devices authorized under the MedRadio rules is required to determine compliance with radiated emission and EIRP limits [see Sections 95.2567, 95.2569, and 95.2579]. The MedRadio rules in the present Section 95.2569(c) (numbered as Section 95.627(g)(3)(i) when originally adopted by the Commission on March 19, 2009) require that a "Commission-approved human body simulator and test technique" be used for testing 401-406 MHz implant transmitters.

FCC will continue to accept devices tested to the procedures in place before 2009, as described below.

Medical implant transmitters shall be tested for emissions and EIRP limit compliance while submersed in a medium that simulates human body tissue with the required dielectric properties. For a transmitter intended to be implanted in a human body, a test set-up as described in the following paragraph must be used to simulate operation of the implant under actual operating conditions. Simple saline solutions do not meet the above criteria.

1) For measurement purposes and to determine compliance with emission limits, the radiating characteristics of a MedRadio implant transmitter placed in a test fixture should approximate those of an implant transmitter placed in a human body.

2) An appropriate human torso simulator (phantom) for testing medical implant transmitters should consist of a cylindrical Plexiglas container, measuring 30 cm in diameter and 76 cm long, with a sidewall thickness of 0.635 cm.

3) The human torso simulator must be completely filled with a tissue-equivalent material that is sufficiently fluidic and flow around the implant without any voids.

4) The permittivity and conductivity of the tissue-equivalent material must match the dielectric parameters of the body tissue-equivalent properties in KDB Publication 865664 at 403.5 MHz. Example tissue mixture recipes are available in IEEE Std 1528-2013. The dielectric parameters must be measured and must satisfy the required target values.

5) All emission measurements shall be made using the above specification at a nominal tissue-equivalent material temperature of 20° C to 25° C.

6) A low-loss mounting grid for the implant inside the container that permits the radiating element or elements of the implant to be positioned vertically and horizontally must be used. The mounting grid shall not perturb the emission results and must also support in a fixed repeatable manner any additional implant leads associated with the therapeutic function.

7) The implant must be mounted 6 cm from the sidewall and centered vertically within the container.

8) The aforementioned liquid-filled phantom with mounting grid shall be placed on a turntable such that the implant transmitter is located at a nominal 1.5 m height above ground and at a 3 m distance from the measurement antenna. Radiated emissions measurements shall then be performed to ensure compliance with the applicable technical specifications.

 



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