1. Scope

1.1 This test method covers measurement of Radio Frequency (RF) induced heating near a passive medical implant and its surroundings during Magnetic Resonance Imaging (MRI).

1.2 This test method is one of those required to determine if the presence of a passive implant may cause injury to the person with the implant during an MRI procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque.

1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is proportional to the static magnetic field strength. Because of possible additional heating, particularly when device dimensions exceed a quarter wavelength, conclusions from measurements made at one frequency may not apply to other frequencies.

1.4 This test method assumes that testing is done on devices that will be entirely inside the body.

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 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 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.

ASTM Standards

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 Standard

NEMA Standard

Keywords

implant; MRI (magnetic resonance imaging); MR safety; RF (radio frequency) heating; Whole body magnetic resonance; Passive implants; RF-induced temperature rise; MRI (magnetic resonance imaging); RF (radio frequency) receivers; Specific absorption rate (SAR);

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2182-02A

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