Significance and Use
This test method is one of those required to determine if the presence of a medical device may cause injury during a magnetic resonance examination and in the magnetic resonance environment. Other safety issues which should be addressed include but may not be limited to magnetically induced force (see Test Method F2052) and RF heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment.
If the maximal torque is less than the product of the longest dimension of the medical device and its weight, then the magnetically induced deflection torque is less than the worst case torque on the device due to gravity. For this condition, it is assumed that any risk imposed by the application of the magnetically induced torque is no greater than any risk imposed by normal daily activity in the Earth's gravitational field. This is conservative; it is possible that greater torques would not pose a hazard to the patient.
This test method alone is not sufficient for determining if an implant is safe in the MR environment.
The sensitivity of the torque measurement apparatus must be greater than 1/10 the “gravity torque,” the product of device weight and the largest linear dimension.
The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.
1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque to the equivalent torque applied by the gravitational force to the implant.
1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.
1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.
1.4 The sensitivity of the torque measurement apparatus must be greater than 1/10 the “gravity torque,” the product of the device's maximum linear dimension and its weight.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.
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
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO13485:2003(E) Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes, definition 3.7
force, magnetic; implant; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety; torque, magnetic: Magnetically-induced properties; Magnetic resonance testing; MRI (magnetic resonance imaging); Passive implants; Torque--surgical implant applications;
ICS Number Code 17.220.20 (Measurement of electrical and magnetic quantities)
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Citing ASTM Standards
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