ASTM F2052-02

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Designation:F2052–02
Standard Test 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 F 2052; 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 F 2119 Test Method for Evaluation of MR Image Artifacts
3
from Passive Implants
1.1 This test method covers the measurement of the mag-
F 2182 Test Method for Measurement of Radio Frequency
netically induced displacement force produced by static mag-
Induced Heating Near Passive Implants During Magnetic
netic field gradients on medical devices and the comparison of
3
Resonance Imaging
that force to the weight of the medical device.
1.2 This test method does not address other possible safety
3. Terminology
issues which include but are not limited to issues of magneti-
3.1 Definitions:
cally induced torque, RF heating, induced heating, acoustic
3.1.1 diamagnetic material—a material whose relative per-
noise, interaction among devices, and the functionality of the
meability is less than unity.
device and the MR system.
3.1.2 ferromagnetic material—a material whose magnetic
1.3 This test method is intended for devices that can be
moments are ordered and parallel producing magnetization in
suspended from a string. Devices which cannot be suspended
one direction.
from a string are not covered by this test method. The weight
3.1.3 magnetic field strength (H in A/m)—strength of the
ofthestringfromwhichthedeviceissuspendedduringthetest
applied magnetic field.
must be less than 1 % of the weight of the tested device.
3.1.4 magnetic induction or magnetic flux density (B in
1.4 This test method shall be carried out in a system in
T)—that magnetic vector quantity which at any point in a
which the direction of the magnetically induced deflection
magnetic field is measured either by the mechanical force
force is horizontal.
experiencedbyanelementofelectriccurrentatthepoint,orby
1.5 The values stated in SI units are to be regarded as
the electromotive force induced in an elementary loop during
standard. Values in parentheses are for information only.
any change in flux linkages with the loop at the point. The
1.6 This standard does not purport to address all of the
magnetic induction is frequently referred to as the magnetic
safety concerns, if any, associated with its use. It is the
field. B isthestaticfieldinanMRsystem.Plaintypeindicates
o
responsibility of the user of this standard to establish appro-
a scalar (for example, B) and bold type indicates a vector (for
priate safety and health practices and determine the applica-
example,B).
bility of regulatory requirements prior to use.
3.1.5 magnetic resonance diagnostic device—a device in-
2. Referenced Documents tended for general diagnostic use to present images which
reflectthespatialdistributionormagneticresonancespectra,or
2.1 ASTM Standards:
both, which reflect frequency and distribution of nuclei exhib-
A 340 Terminology of Symbols and Definitions Relating to
2
iting nuclear magnetic resonance. Other physical parameters
Magnetic Testing
derived from the images or spectra, or both, may also be
F 1542 Specification for the Requirements and Disclosure
3
produced.
of Self-Closing Aneurysm Clips
3.1.6 magnetic resonance (MR) environment—area within
the 5 gauss (G) line of an MR system.
1 3.1.7 magnetic resonance equipment (MR equipment)—
This test method is under the jurisdiction ofASTM Committee F04 on Medical
medical electrical equipment which is intended for in-vivo
& Surgical Materials & Devices and is the direct responsibility of Subcommittee
F04.15 on Materials Test Methods.
magnetic resonance examination of a patient. The MR equip-
Current edition approved Nov. 10, 2002. Published December 2002. Originally
ment comprises all parts in hardware and software from the
approved in 2000. Last previous edition approved in 2000 as F 2052 – 00.
2 supply mains to the display monitor. The MR equipment is a
Annual Book of ASTM Standards, Vol 03.04.
3
Annual Book of ASTM Standards, Vol 13.01. Programmable Electrical Medical System (PEMS).
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F2052–02
3.1.8 magnetic resonance system (MR system)—ensemble 6. Apparatus
of MR equipment, accessories, including means for display,
6.1 The test fixture consists of a sturdy nonmagnetic struc-
control, energy supplies, and the MR environment.
ture capable of holding the test device in the proper pos
...