ASTM F2052-14
(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
5.1 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 F2213) and RF heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment.
5.2 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's gravitational field. This statement does not constitute an acceptance criterion, however it is provided for a conservative reference point. It is possible that a greater magnetically induced deflection force can be acceptable and would not harm a patient. For forces greater than gravity the location of the implant and means of fixation must be considered. Magnetically induced deflection forces greater than the force of gravity may be acceptable when they can be justified for the specific case.
5.3 A deflection of less than 45° at the location of the maximum spatial gradient of the static magnetic field in one MR system does not preclude a deflection exceeding 45° in a system with a higher field strength or larger static field spatial gradients.
5.4 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 horizontal bore MR system with a static magnetic filed oriented horizontally and parallel to the MR system bore.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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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Designation: F2052 − 14
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2119Test Method for Evaluation of MR Image Artifacts
from Passive Implants
1.1 This test method covers the measurement of the mag-
F2182Test 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.
F2213Test 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
F2503Practice 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.
3
2.2 Other Standards:
1.3 This test method is intended for devices that can be
IEC60601–2–33Ed. 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 Thistestmethodshallbecarriedoutinahorizontalbore
ISO 14971Medical devices - Application of risk manage-
MR system with a static magnetic filed oriented horizontally
ment to medical devices
and parallel to the MR system bore.
1.5 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
standard. 3.1 Definitions:
3.1.1 diamagnetic material, n—a material whose relative
1.6 This standard does not purport to address all of the
permeability is less than unity.
safety concerns, if any, associated with its use. It is the
3.1.2 ferromagnetic material, n—amaterialwhosemagnetic
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), n—strength of the
2. Referenced Documents
applied magnetic field.
2
2.1 ASTM Standards:
3.1.4 magnetic induction or magnetic flux density (B in T),
n—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical experiencedbyanelementofelectriccurrentatthepoint,orby
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
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 May 15, 2014. Published August 2014. Originally
ε1
magnetic induction is frequently referred to as the magnetic
approved in 2000. Last previous edition approved in 2006 as F2052–06 . DOI:
10.1520/F2052-14.
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, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2052 − 14
field. B is the static field in a MR system. Plain type indicates 3.1.13 paramagnetic material, n—a material having a rela-
o
a scalar (for example, B) and bold type indicates a vector (for tive permeability which is slightly greater than unity, and
which is practically independent of the magnetizing force.
example,B).
3.1.14 tesla, (T), n—the SI unit of magnetic induction equal
3.1.5 magnetic resonance diagnostic device, n—a device
4
to 10 gauss (G).
intended
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F2052 − 06 F2052 − 14
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 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.
1
ε NOTE—Paragraph X1.3 was added editorially in May 2006.
1. 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. horizontal bore MR system with a static magnetic filed oriented horizontally and parallel to the MR system bore.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.No other units
of measurement are included in this standard.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
3
2.2 Other Standards:
IEC 60601–2–33 Ed. 2.0 Medical Electronic Equipment—Part 2: Particular Requirements for the Safety of Magnetic Resonance
Equipment for Medical Diagnosis
ISO 13485:2003(E) Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes, definition 3.7
ISO 14971 Medical devices - Application of risk management to medical devices
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved April 28, 2006May 15, 2014. Published March 2006August 2014. Originally approved in 2000. Last previous edition approved in 20022006 as
ε1
F2052 – 02.F2052 – 06 . DOI: 10.1520/F2052-06E01.10.1520/F2052-14.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2052 − 14
3. Terminology
3.1 Definitions:
3.1.1 diamagnetic material—material, n—a material whose relative permeability is less than unity.
3.1.2 ferromagnetic material—material, n—a material whose magnetic moments are ordered and parallel producing magneti-
zation in one direction.
3.1.3 magnetic field strength (H in A/m)A/m), n——strength of the applied magnetic field.
3.1.4 magnetic induction or magnetic flux density ((BB in T), Tn—)—that magnetic vector quantity which at any point in a
magnetic field is measured either by the mechanical force experienced by an element of electric current at the point, or by
...
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