ASTM F2213-02
Historical Standard: ASTM F2213-02 Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment
SUPERSEDED (see Active link, below)
ASTM F2213
1. Scope
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 passive implants (implants that function without the supply of electrical power) 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 the issue of magnetically induced force due to spatial gradients in the static magnetic field.
1.3 The torque considered here is the 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.
1.4 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
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
Other Standards
ISO13485:2003(E) Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes, definition 3.7Keywords
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 Code
ICS Number Code 17.220.20 (Measurement of electrical and magnetic quantities)
DOI: 10.1520/F2213-02
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