New Test Method for measurement of gradient magnetic field induced heating on or near non-active implants during magnetic resonance imaging
1. Scope
1. Scope
1.1 This test method covers measurement of gradient-induced heating on a passive medical implant and its surroundings during magnetic resonance imaging (MRI).
1.2 This test method is one required to determine if the presence of a passive implant may cause injury to the patient with the implant during an MR procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque, as well as radiofrequency induced heating and proper device function while in various configurations in the MR environment.
1.3 The amount of gradient induced heating will depend on the |dB/dt| rms (root mean square value of the time rate of change of the magnetic field) and on the gradient field orientation.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body. For other implantation conditions (for example, external fixation devices, percutaneous
needles, catheters or tethered devices such as ablation probes), modifications of this test method are necessary.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1 This test method is under the jurisdiction of ASTM Committee committeeTitle and is the direct responsibility of Subcommittee subcommitteeTitle.
Current edition approved XXX. XX, XXXX. Published XX XXXX. DOI:10.1520/XXXXX-XX
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1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of international Standards, Guidesand Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Keywords
magnetic induction; gradient-induced heating; passive implants; non-active implants; MRI scanning; pulsed magnetic fields; MR Conditional implants
Rationale
This test method is necessary covering non-active implants for an MR interaction when exposed to pulsed magnetic fields of the gradient maschine of an MR scanner. Especially it is necessary to consider the individual 3-dimensional structure in precise manner compared to flat implants and devices considered in ISO/TS 10974 gradient-induced heating test method
WK95470 - New Test Method for measurement of gradient magnetic field induced heating on or near non-active implants during magnetic resonance imaging | ASTM
