Compliance Testing

The IT'IS Foundation is regarded by many as the leading, truly independent institution for compliance testing with EMF safety guidelines. IT'IS is not only the pacemaker for near-field analysis tools, it has also taken a leading role in developing the most accurate and well-suited testing procedures. The Foundation has the most advanced near-field laboratory, capable of performing dosimetric and near-field evaluations starting from a few MHz to well above 10 GHz as well as temperature measurements in EMF-hostile environments. Medical device manufacturers can benefit from an entire range of services for compliance testing, including MRI safety of implanted devices as well as modeling and testing of implantable or on-body devices for SAR limits.

MRI Safety of Medical Implants

The combined application of numerical modeling and experimental evaluation is the only methodology to demonstrate the MRI safety of implants. This is the reason why a new ISO/ IEC standard is being drafted on active implantable medical devices (AIMD). A new technical specification containing sections on exposure systems, measurement setups, probes, testing methodology, uncertainty assessment, tissue simulating media, and reporting has been developed. The Foundation is the first test laboratory worldwide offering experimental compliance evaluations following these specifications. Test suites such as the MITS 1.5 or the MITS 3.0 from ZMT Zurich Med Tech are available to perform experiments under very well-defined field conditions for RF heating and EMC exposure. The magnitude and polarization are controlled independently of the load using isotopic H-field probes combined with EASY4MRI from SPEAG for MR applications. Elliptical or custom-made phantoms filled with high or low conductive media can be positioned inside a 16-rung RF birdcage coil that represents a worst-case approximation of the coils used in available 1.5T and 3T MRI machines. The pictures on this page show examples of an evaluation in an elliptical phantom using a MITS 1.5.

Measurements at IT'IS are conducted with the birdcage in vertical orientation, permitting the dosimetric near-field scanner robot DASY5 to perform measurements along a pre-defined path or within a defined volume around the implant during the RF field exposition. The set-up can be used to perform E-field, H-field, specific absorption rate (SAR) and temperature measurements with a robot-scanned grid. This configuration and the extensive testing experience of our team provides the basis that enables a large variety of measurements to be performed for different implants in a much shorter time than in a clinical MRI environment. Lowest test result uncertainty is achieved by comparing the modeling outcome and measurement results with unmet accuracy.

Our Expertise

To ensure that we have first-hand knowledge of the latest developments in the relevant standards, the IT'IS Foundation greatly benefits from its active involvement in several standards committees, as well as its consultancy to various government agencies such as the ISO/TC 150/SC 6/JWG2 and IEC SC 62B/JWG1, IEC MT 40, the International Commission on Non-Ionizing Radiation Protection (ICNIRP, CH), and the Food and Drug Administration (FDA, USA).

The IT'IS Foundation is equipped with advanced measurement equipment and numerical simulation infrastructure to carry out the necessary work. The facilities on site include:

• A facility for dosimetric compliance testing shared with Schmid & Partner Engineering AG (SPEAG), which meets the requirements for dosimetric evaluations according to international standards.  The equipment includes SPEAG equipment (DASY, iSAR and EASY) and Zurich Med Tech equipment (MITS 1.5, MITS 3.0 and MITS Gradient).
• A semi-anechoic chamber (L x W x H = 7 x 5 x 2.9 m) with an integrated DASY5NEO system that can be utilized for all research activities involving dosimetric, near-field and far-field evaluations, the optimization and synthesis of body-mounted transmitters, implants, desktop applications, exposure setups, calibration procedures, EMI tests, MRI safety tests, compliance testing of implants, etc.
• Two reverberation chambers (L x W x H = 4 x 3 x 2.9 m and 3.7 x 2.2 x 2.7 m). Both chambers are equipped with two mechanical stirrers and provide controlled and consistent environments for EM emissions and immunity testing, as well as shielding effectiveness and susceptibility testing of electromagnetic equipment.
• Measurement equipment, such as spectrum and network analyzers, signal and waveform generators, radiocommunication testers, amplifiers, power meters, oscilloscopes, electric and magnetic field probes, antennas and incubators.
• Fast and powerful computer hardware that is continually being upgraded, including multi-core processing hardware.