Influence of patient head definition on induced E‐fields during MR examination

Author:

Goren Tolga1ORCID,Reboux Sylvain2,Farcito Silvia1ORCID,Lloyd Bryn12ORCID,Kuster Niels13ORCID

Affiliation:

1. IT'IS Foundation Zurich Switzerland

2. ZMT Zurich MedTech AG Zurich Switzerland

3. Department of Information Technology and Electrical Engineering Swiss Federal Institute of Technology (ETH) Zurich Switzerland

Abstract

AbstractPurposeRadiofrequency (RF) exposure during MR examination is limited by IEC 60601‐2‐33 to prevent thermal hazards to patients. These limits are also the basis to derive the maximum induced field for the demonstration of MR safety of implants per ISO/TS 10974 (2018). One limit is the head‐averaged specific absorption rate (SAR), for which the head extent is defined differently by MR and implant vendors. The purpose of this technical note is to inform MR safety stakeholders on the sensitivity of safety evaluations due to different head extent definitions.MethodsRF distributions from the validated MRIxViP exposure libraries of 12 high‐resolution human anatomical models were scaled to the normative SAR limits for different definitions of the head extent to compare the corresponding induced SAR and electric (E‐)field levels.ResultsThe definitions of the head extent used by major implant vendors and defined in ISO/TS 10974 (2018) are larger than those introduced in IEC 60601‐2‐33 (2022), resulting in lower RF head exposure by up to 2.4 dB (factor 1.7). Other proposed definitions of the head result in intermediate values.ConclusionThe different head extents result in different maximum RF exposures affecting the risk assessment by up to a factor of 1.7. The results of this study can be used to estimate the additional uncertainty in safety assessments. Future revisions of MR standards should eliminate this inconsistency.

Funder

European Partnership on Metrology

Staatssekretariat für Bildung, Forschung und Innovation

Publisher

Wiley

Subject

Radiology, Nuclear Medicine and imaging

Reference10 articles.

1. IEC 60601‐2‐33 ED4.0: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.2022.

2. ASTM F2182 ‐ 19e2. Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging.2019.

3. ISO/TS 10974. Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.2018.

4. Team ISO/IEC Joint Directives Management.ISO/IEC Directives Part 2: principles and rules for the structure and drafting of ISO and IEC documents.2021.

5. Development of a new generation of high-resolution anatomical models for medical device evaluation: the Virtual Population 3.0

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