ASTM F2052-00

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment

SCOPE
1.1 This standard test method covers the measurement of the magnetically induced displacement force produced by the spatial gradients of a magnetic field on passive implants (implants that function without the supply of electrical power) and the comparison of that force to the weight of the implant.
1.2 This method does not address the issues of magnetically induced torque or RF heating.
1.3 This method is intended for devices that can be suspended from a thin string. Devices which cannot be suspended from a thin string are not covered by this test method.
1.4 The weight of the thin string from which the device is suspended during the test must be less than 1% of the weight of the tested device.
1.5 This method is applicable only to magnet systems in which the direction of the magnetic field (and the direction of the magnetically induced deflection force) is horizontal.

General Information

• Status: Historical
• Publication Date: 09-Jul-2000
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaced By: ASTM F2052-02 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 10-Jul-2000
• Referred By: ASTM F2182-19e2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
• Effective Date: 10-Jul-2000
• Referred By: ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 10-Jul-2000
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 10-Jul-2000
• Referred By: ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
• Effective Date: 10-Jul-2000
• Referred By: ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
• Effective Date: 10-Jul-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2052 – 00
Standard Test Method for
Measurement of Magnetically Induced Displacement Force
on Passive Implants 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 experienced by an element of electric current at the point, or by
the electromotive force induced in an elementary loop during
1.1 This standard test method covers the measurement of
any change in flux linkages with the loop at the point. The
the magnetically induced displacement force produced by the
magnetic induction is frequently referred to as the magnetic
spatial gradients of a magnetic field on passive implants
field. B is the static field in an MR scanner.
o
(implants that function without the supply of electrical power)
3.1.5 magnetic resonance diagnostic device—a device in-
and the comparison of that force to the weight of the implant.
tended for general diagnostic use to present images which
1.2 This method does not address the issues of magnetically
reflect the spatial distribution and/or magnetic resonance spec-
induced torque or RF heating.
tra which reflect frequency and distribution of nuclei exhibiting
1.3 This method is intended for devices that can be sus-
nuclear magnetic resonance. Other physical parameters derived
pended from a thin string. Devices which cannot be suspended
from the images and/or spectra may also be produced.
from a thin string are not covered by this test method.
3.1.6 magnetic resonance (MR) environment—refers to the
1.4 The weight of the thin string from which the device is
electromagnetic environment present in the vicinity of an MR
suspended during the test must be less than 1% of the weight
scanner within the 5 gauss line.
of the tested device.
3.1.7 magnetic resonance imaging (MRI)—imaging tech-
1.5 This method is applicable only to magnet systems in
nique that uses static and time varying magnetic fields to
which the direction of the magnetic field (and the direction of
provide images of tissue by the magnetic resonance of nuclei.
the magnetically induced deflection force) is horizontal.
3.1.8 magnetically induced displacement force— force pro-
2. Referenced Documents
duced when a magnetic object is exposed to the spatial gradient
of a magnetic field. This force will tend to cause the object to
2.1 ASTM Standards:
translate in the gradient field.
A 340 Standard Terminology of Symbols and Definitions
3.1.9 paramagnetic material—a material having a relative
Relating to Magnetic Testing
permeability which is slightly greater than unity, and which is
F 1542 Standard Specification for the Requirements and
practically independent of the magnetizing force.
Disclosure of Self-Closing Aneurysm Clips
3.1.10 passive implant—an implant that serves its function
3. Terminology
without the supply of electrical power.
3.1.11 tesla, (T)—the SI unit of magnetic induction equal to
3.1 Definitions:
4
10 gauss.
3.1.1 diamagnetic material—a material whose relative per-
meability is less than unity.
4. Summary of Test Method
3.1.2 ferromagnetic material—a material whose magnetic
4.1 An implant is suspended by a fine string at the point in
moments are ordered and parallel producing magnetization in
a magnetic field that will produce the greatest magnetically
one direction.
induced deflection. The angular deflection of the string from
3.1.3 magnetic field strength (H in A/m)—strength of the
the vertical is measured. If the implant deflects less than 45°,
applied magnetic field.
then the magnetically induced deflection force is less than the
3.1.4 magnetic induction or magnetic flux density (B in
force on the implant due to gravity (its weight).
T)—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force
5. Significance and Use
5.1 This test is one of those required to determine if the
1 presence of a passive implant may cause injury to the person
This test method is under the jurisdiction of ASTM Committee F04 on Medical
with the implant during an MRI scan and in the vicinity of the
& Surgical Materials & Devices and is the direct responsibility of Subcommittee
F04.15 on Materials Test Methods.
MRI scanner. Other safety issues which should be addressed
Current edition approved July 10, 2000. Published September 2000.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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