Z43 at ISO 10974 JWG in Prague

The ISO 10974 Joint Working Group (JWG) met from November 11 – 13, 2019 in Prague to work on the standard for assuring the safety of active implantable medical devices (AIMD) during magnetic resonance (MR) examinations. The Z43 team – represented by Dr. Tolga Goren and Dr. Aiping Yao from IT'IS, and Dr. Nassim Nasseri from ZMT Zurich MedTech – presented their latest results for contribution to the standard and development of the scientific rationale behind it, in preparation for the first normative edition, due to be content-frozen in 2020 with anticipated publication in 2022.

The Z43 presentations highlighted new results on the following topics:

• effects of MR system shimming on B1+ homogeneity and patient specific absorption rate (SAR), which can be accessed easily for risk assessment tailored to each implant and region of interest with the powerful MRIxViP Libraries and the IMAnalytics toolset;
• rationale of selecting homogeneous tissue simulating media to match the average wavelength in the AIMD or in the surrounding tissue;
• a comprehensive reassessment of the numerical targets of the SAIMD-1-200mm and the new SAIMD-1-100mm with a rigorous grid study;
• assessment of the (worst-case) temperature rise and thermal dose implications of the definition of SAR averaging as implemented in IEC 60601-2-33;
• a new annex describing the transfer function method, its rationale, and validation of transfer function measurement systems with ZMT's SAIMD-U validation device;
• the latest iteration of the new Tier 4- method of modeling implant response more accurately in a mixed-tissue environment, combining the speed and coverage of Tier 3 with the precision of Tier 4.

The meeting in the beautiful city of Prague, included some tasty dinners with colleagues and friends, and of course more than one glass of the world-famous Czech beer!

The official group photo of the ISO 10974 JWG Meeting in Prague, taken from a different angle.

Check out the following links for more information on using the MRIxViP databases (now at Version 2.0) with ZMT's IMAnalytics to assess population risk. To learn more about our efforts in MRI safety evaluations for active implants and more, contact our colleagues at IT’IS at customized@itis.swiss.