ASTM F2052-06e1
(Test Method)Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
SIGNIFICANCE AND USE
This test method is one of those required to determine if the presence of a medical device may cause injury to individuals during an MR examination and in the MR environment. Other safety issues which should be addressed include but may not be limited to magnetically induced torque (see Test Method F 2213) and RF heating (see Test Method F 2182). The terms and icons in Practice F 2503 should be used to mark the device for safety in the magnetic resonance environment.
If the device deflects less than 45°, then the magnetically induced deflection force is less than the force on the device due to gravity (its weight). For this condition, it is assumed that any risk imposed by the application of the magnetically induced force is no greater than any risk imposed by normal daily activity in the Earth’gravitational field.
A deflection of less than 45° at the location of the maximum static magnetic field gradient in one MR system does not preclude a deflection exceeding 45° in a system with a higher field strength or larger static field gradients.
This test method alone is not sufficient for determining if a device is safe in the MR environment.
SCOPE
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients on medical devices and the comparison of that force to the weight of the medical device.
1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced torque, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.
1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 1 % of the weight of the tested device.
1.4 This test method shall be carried out in a system in which the direction of the magnetically induced deflection force is horizontal.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.
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 requirements prior to use.
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Standards Content (Sample)
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Designation: F2052 − 06
StandardTest Method for
Measurement of Magnetically Induced Displacement Force
on Medical Devices in the Magnetic Resonance
1
Environment
This standard is issued under the fixed designation F2052; 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 (´) indicates an editorial change since the last revision or reapproval.
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´ NOTE—Paragraph X1.3 was added editorially in May 2006.
1. Scope F2119 Test Method for Evaluation of MR Image Artifacts
from Passive Implants
1.1 This test method covers the measurement of the mag-
F2182 Test Method for Measurement of Radio Frequency
netically induced displacement force produced by static mag-
Induced Heating On or Near Passive Implants During
netic field gradients on medical devices and the comparison of
Magnetic Resonance Imaging
that force to the weight of the medical device.
F2213 Test Method for Measurement of Magnetically In-
1.2 This test method does not address other possible safety
duced Torque on Medical Devices in the Magnetic Reso-
issues which include but are not limited to issues of magneti-
nance Environment
cally induced torque, RF heating, induced heating, acoustic
F2503 Practice for Marking Medical Devices and Other
noise, interaction among devices, and the functionality of the
Items for Safety in the Magnetic Resonance Environment
device and the MR system.
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2.2 Other Standards:
1.3 This test method is intended for devices that can be
IEC 60601–2–33 Ed. 2.0 Medical Electronic Equipment—
suspended from a string. Devices which cannot be suspended
Part2:ParticularRequirementsfortheSafetyofMagnetic
from a string are not covered by this test method. The weight
Resonance Equipment for Medical Diagnosis
ofthestringfromwhichthedeviceissuspendedduringthetest
ISO 13485:2003(E) Medical Devices—Quality Manage-
must be less than 1 % of the weight of the tested device.
ment Systems—Requirements for Regulatory Purposes,
definition 3.7
1.4 This test method shall be carried out in a system in
which the direction of the magnetically induced deflection
force is horizontal. 3. Terminology
1.5 The values stated in SI units are to be regarded as 3.1 Definitions:
standard. Values in parentheses are for information only. 3.1.1 diamagnetic material—a material whose relative per-
meability is less than unity.
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3.1.2 ferromagnetic material—a material whose magnetic
responsibility of the user of this standard to establish appro-
moments are ordered and parallel producing magnetization in
priate safety and health practices and determine the applica- one direction.
bility of regulatory requirements prior to use.
3.1.3 magnetic field strength (H in A/m)—strength of the
applied magnetic field.
2. Referenced Documents
3.1.4 magnetic induction or magnetic flux density (B in
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2.1 ASTM Standards:
T)—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force
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experiencedbyanelementofelectriccurrentatthepoint,orby
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
the electromotive force induced in an elementary loop during
F04.15 on Material Test Methods.
any change in flux linkages with the loop at the point. The
Current edition approved April 28, 2006. Published March 2006. Originally
magnetic induction is frequently referred to as the magnetic
approved in 2000. Last previous edition approved in 2002 as F2052 – 02. DOI:
10.1520/F2052-06E01.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2052 − 06
field. B isthestaticfieldinanMRsystem.Plaintypeindicates 3.1.13 paramagnetic material—a material having a relative
o
a scalar (for example, B) and bold type indicates a vector (for permeability which is slightly greater than unity, and which is
practically independent of the magnetizing force.
example,B).
3.1.14 tesla, (T)—the SI unit of magnetic induction equal to
3.1.5 magnetic resonance diagnostic device—a device in-
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10 gauss (G).
tended for general diagnostic use to present images which
r
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