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Significance and Use
This test method describes a test procedure for evaluating the RF-induced temperature rise associated with an MR procedure involving a specific frequency of RF irradiation of an implant. The heating measurements are made twice, once with the implant and then repeated at the same location without the implant. These two measurements estimate the local SAR and the local additional temperature rise with the implant.
The results may be used as an input to a computational model for estimating temperature rise due to the presence of that implant in a patient. The combination of the test results and the computational model results may then be used to help assess the safety of a patient with the implant during an MR scan.
1.1 This test method covers measurement of radio frequency (RF) induced heating on or near 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 proper device function while in various configurations in the MR environment.
1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. While the focus in this test method is on 1.5 Tesla (T) or 3 Tesla cylindrical bore MR systems, the RF-induced temperature rise for an implant in MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the method described herein.
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 This test method applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of the IEC Standard 60601-2-33, Ed. 2.0, with a whole body RF transmit coil as defined in section 2.2.100. The RF coil is assumed to have quadrature excitation.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
IEC Standard60601-2-33,Ed.2.0 Medical Electrical Equipment--Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis, 2002
NEMA StandardNEMAMS8—2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)