ASTM F2052-06

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2052–06
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 2213 Test Method for Measurement of Magnetically In-
duced Torque on Medical Devices in the Magnetic Reso-
1.1 This test method covers the measurement of the mag-
nance Environment
netically induced displacement force produced by static mag-
F 2503 Practice for Marking Medical Devices and Other
netic field gradients on medical devices and the comparison of
Items for Safety in the Magnetic Resonance Environment
that force to the weight of the medical device.
3
2.2 Other Standards:
1.2 This test method does not address other possible safety
IEC 60601–2–33 Ed. 2.0 Medical Electronic Equipment—
issues which include but are not limited to issues of magneti-
Part2:ParticularRequirementsfortheSafetyofMagnetic
cally induced torque, RF heating, induced heating, acoustic
Resonance Equipment for Medical Diagnosis
noise, interaction among devices, and the functionality of the
ISO 13485:2003(E) Medical Devices—Quality Manage-
device and the MR system.
ment Systems—Requirements for Regulatory Purposes,
1.3 This test method is intended for devices that can be
definition 3.7
suspended from a string. Devices which cannot be suspended
from a string are not covered by this test method. The weight
3. Terminology
ofthestringfromwhichthedeviceissuspendedduringthetest
3.1 Definitions:
must be less than 1 % of the weight of the tested device.
3.1.1 diamagnetic material—a material whose relative per-
1.4 This test method shall be carried out in a system in
meability is less than unity.
which the direction of the magnetically induced deflection
3.1.2 ferromagnetic material—a material whose magnetic
force is horizontal.
moments are ordered and parallel producing magnetization in
1.5 The values stated in SI units are to be regarded as
one direction.
standard. Values in parentheses are for information only.
3.1.3 magnetic field strength (H in A/m)—strength of the
1.6 This standard does not purport to address all of the
applied magnetic field.
safety concerns, if any, associated with its use. It is the
3.1.4 magnetic induction or magnetic flux density (B in
responsibility of the user of this standard to establish appro-
T)—that magnetic vector quantity which at any point in a
priate safety and health practices and determine the applica-
magnetic field is measured either by the mechanical force
bility of regulatory requirements prior to use.
experiencedbyanelementofelectriccurrentatthepoint,orby
2. Referenced Documents the electromotive force induced in an elementary loop during
2 any change in flux linkages with the loop at the point. The
2.1 ASTM Standards:
magnetic induction is frequently referred to as the magnetic
F2119 Test Method for Evaluation of MR Image Artifacts
field. B isthestaticfieldinanMRsystem.Plaintypeindicates
from Passive Implants o
a scalar (for example, B) and bold type indicates a vector (for
F 2182 Test Method for Measurement of Radio Frequency
example,B).
Induced Heating Near Passive Implants During Magnetic
3.1.5 magnetic resonance diagnostic device—a device in-
Resonance Imaging
tended for general diagnostic use to present images which
reflectthespatialdistributionormagneticresonancespectra,or
1
both, which reflect frequency and distribution of nuclei exhib-
This test method is under the jurisdiction ofASTM Committee F04 on Medical
& Surgical Materials & Devices and is the direct responsibility of Subcommittee
iting nuclear magnetic resonance. Other physical parameters
F04.15 on Materials Test Methods.
derived from the images or spectra, or both, may also be
Current edition approved March 1, 2006. Published March 2006. Originally
produced.
approved in 2000. Last previous edition approved in 2002 as F 2052 – 02.
2
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
3
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.
1

---------------------- Page: 1 ----------------------
F2052–06
3.1.6 magnetic resonance (MR) environment—volume 5. Significance and Use
within the 0.50 mT (5 gauss (
...