ASTM F2213-02

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Designation: F 2213 – 02
Standard Test Method for
Measurement of Magnetically Induced Torque on Passive
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Implants in the Magnetic Resonance Environment
This standard is issued under the fixed designation F 2213; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 60601-2-33 Ed. 2.0 Medical Electrical Equipment—Part 2:
Particular Requirements for the Safety of Magnetic Reso-
1.1 This test method covers the measurement of the mag-
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nance Equipment for Medical Diagnosis, 2002
netically induced torque produced by the static magnetic field
in the magnetic resonance environment on passive implants
3. Terminology
(implants that function without the supply of electrical power)
3.1 Definitions—For the purposes of this test method, the
and the comparison of that torque to the equivalent torque
definitions in 3.1.1-3.1.18 shall apply:
applied by the gravitational force to the implant.
3.1.1 diamagnetic material—a material whose relative per-
1.2 This test method does not address the issue of magneti-
meability is less than unity.
cally induced force due to spatial gradients in the static
3.1.2 ferromagnetic material—a material whose magnetic
magnetic field.
moments are ordered and parallel producing magnetization in
1.3 The torque considered here is the static torque due to the
one direction.
interaction of the MRI static magnetic field with the magneti-
3.1.3 magnetic induction or magnetic flux density (B in
zation in the implant. The dynamic torque due to interaction of
T)—that magnetic vector quantity which at any point in a
the static field with eddy currents induced in a rotating device
magnetic field is measured either by the mechanical force
is not addressed in this test method.
experienced by an element of electric current at the point, or by
1.4 This standard does not purport to address all of the
the electromotive force induced in an elementary loop during
safety concerns, if any, associated with its use. It is the
any change in flux linkages with the loop at the point. The
responsibility of the user of this standard to establish appro-
magnetic induction is frequently referred to as the magnetic
priate safety and health practices and determine the applica-
field. B is the static field in an MR system. Plain type indicates
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bility of regulatory limitations prior to use.
a scalar (for example, B) and bold type indicates a vector (for
2. Referenced Documents example, B).
3.1.4 magnetic field strength (H in A/m)—strength of the
2.1 ASTM Standards:
applied magnetic field.
A 340 Terminology of Symbols and Definitions Relating to
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3.1.5 magnetic resonance (MR)—resonant absorption of
Magnetic Testing
electromagnetic energy by an ensemble of atomic particle
F 1542 Specification for the Requirements and Disclosure
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situated in a magnetic field.
of Self-Closing Aneurysm Clips
3.1.6 magnetic resonance diagnostic device—a device in-
F 2052 Test Method for Measurement of Magnetically In-
tended for general diagnostic use to present images which
duced Displacement Force on Passive Implants in the
3 reflect the spatial distribution or magnetic resonance spectra, or
Magnetic Resonance Environment
both, which reflect frequency and distribution of nuclei exhib-
F 2119 Test Method for Evaluation of MR Image Artifacts
3 iting nuclear magnetic resonance. Other physical parameters
from Passive Implants
derived from the images or spectra, or both, may also be
F 2182 Test Method for Measurement of Radio Frequency
produced.
Induced Heating Near Passive Implants During Magnetic
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3.1.7 magnetic resonance (MR) environment—area within
Resonance Imaging
the 5 gauss (G) line of an MR system.
2.2 IEC Standard:
3.1.8 magnetic resonance equipment—medical electrical
equipment which is intended for in-vivo magnetic resonance
examination of a patient. The MR equipment comprises all
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This test method is under the jurisdiction of ASTM Committee F04 on Medical
parts in hardware and software from the supply mains to the
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Nov. 10, 2002. Published February 2003.
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Annual Book of ASTM Standards, Vol 03.04. Available from the International Electrotechnical Commission (IEC), 3 rue de
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Annual Book of ASTM Standards, Vol 13.01. Varembe, Case postale 131, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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NOTICE: This standard has either been superce
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