NEWS
06/03/2020

Z43 at ISO 10974 JWG in Washington DC

The ISO 10974 Joint Working Group (JWG) met March 4-6, 2020 at the new AAMI headquarters near Washington, DC, to work on the standard for assuring the safety of active implantable medical devices (AIMD) during magnetic resonance (MR) examinations. The IT'IS Foundation 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 October this year with comment resolution in 2021 and anticipated publication in 2022. At the meeting, the newly published ASTM F2182-19e standard and the upcoming publication of PC76, a horizontal standard for MR compatibility of cardiac AIMD, were also discussed.
 
The Z43 presentations highlighted new results on the following topics:

  • Development and FDA qualification of the Medical Device Development Tool, IMAnalytics with MRIxViP;
  • Development of a transfer function annex for measurement system validation;
  • Kickoff of the round-robin measurement of ZMT's SAIMD-U validation device

To learn more about our efforts in MRI safety evaluations for active implants and more, contact us at customized@itis.swiss.