ASTM F2182-11a
(Test Method)Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
SIGNIFICANCE AND USE
This test method describes a test procedure for evaluating the RF-induced temperature rise associated with an MR procedure involving a specific frequency of RF irradiation of an implant. The heating measurements are made twice, once with the implant and then repeated at the same location without the implant. These two measurements estimate the local SAR and the local additional temperature rise with the implant.
The results may be used as an input to a computational model for estimating temperature rise due to the presence of that implant in a patient. The combination of the test results and the computational model results may then be used to help assess the safety of a patient with the implant during an MR scan.
SCOPE
1.1 This test method covers measurement of radio frequency (RF) induced heating on or near a passive medical implant and its surroundings during magnetic resonance imaging (MRI).
1.2 This test method is one required to determine if the presence of a passive implant may cause injury to the patient with the implant during an MR procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque, as well as proper device function while in various configurations in the MR environment.
1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. While the focus in this test method is on 1.5 Tesla (T) or 3 Tesla cylindrical bore MR systems, the RF-induced temperature rise for an implant in MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the method described herein.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body. For other implantation conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes), modifications of this test method are necessary.
1.5 This test method applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of the IEC Standard 60601-2-33, Ed. 2.0, with a whole body RF transmit coil as defined in section 2.2.100. The RF coil is assumed to have quadrature excitation.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 limitations prior to use.
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Designation: F2182 − 11a
Standard Test Method for
Measurement of Radio Frequency Induced Heating On or
Near Passive Implants During Magnetic Resonance
1
Imaging
This standard is issued under the fixed designation F2182; 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 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This test method covers measurement of radio fre-
responsibility of the user of this standard to establish appro-
quency (RF) induced heating on or near a passive medical
priate safety and health practices and determine the applica-
implant and its surroundings during magnetic resonance imag-
bility of regulatory limitations prior to use.
ing (MRI).
2. Referenced Documents
1.2 This test method is one required to determine if the
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presence of a passive implant may cause injury to the patient
2.1 ASTM Standards:
with the implant during an MR procedure. Other safety issues
F2052Test Method for Measurement of Magnetically In-
that should be addressed include magnetically induced dis-
duced Displacement Force on Medical Devices in the
placement force and torque, as well as proper device function
Magnetic Resonance Environment
while in various configurations in the MR environment.
F2119Test Method for Evaluation of MR Image Artifacts
from Passive Implants
1.3 The amount of RF-induced temperature rise for a given
F2213Test Method for Measurement of Magnetically In-
specific absorption rate (SAR) will depend on the RF
duced Torque on Medical Devices in the Magnetic Reso-
frequency, which is dependent on the static magnetic field
nance Environment
strength of the MR system.While the focus in this test method
F2503Practice for Marking Medical Devices and Other
is on 1.5Tesla (T) or 3Tesla cylindrical bore MR systems, the
Items for Safety in the Magnetic Resonance Environment
RF-induced temperature rise for an implant in MR systems of
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2.2 IEC Standard:
other static magnetic field strengths or magnet designs can be
60601-2-33, Ed. 2.0Medical Electrical Equipment—Part 2:
evaluated by suitable modification of the method described
Particular Requirements for the Safety of Magnetic Reso-
herein.
nance Equipment for Medical Diagnosis, 2002
1.4 Thistestmethodassumesthattestingisdoneondevices
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2.3 NEMA Standard:
that will be entirely inside the body. For other implantation
NEMA MS 8—2008Characterization of the Specific Ab-
conditions (for example, external fixation devices, percutane-
sorption Rate for Magnetic Resonance Imaging Systems
ous needles, catheters or tethered devices such as ablation
probes), modifications of this test method are necessary.
3. Terminology
1.5 This test method applies to whole body magnetic 3.1 Definitions:
resonance equipment, as defined in section 2.2.103 of the IEC
3.1.1 gelled saline—phantom medium consisting of sodium
Standard 60601-2-33, Ed. 2.0, with a whole body RF transmit chloride and polyacrylic acid or sodium chloride and hydroxy-
coil as defined in section 2.2.100. The RF coil is assumed to
ethylcellulose in water as specified in this test method.
have quadrature excitation.
3.1.2 implant,n—inmedicine,anobject,structure,ordevice
1.6 The values stated in SI units are to be regarded as intendedtoresidewithinthebodyfordiagnostic,prosthetic,or
other therapeutic purposes.
standard. No other units of measurement are included in this
standard.
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
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical Standards volume information, refer to the standard’s Document Summary page on
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee the ASTM website.
3
F04.15 on Material Test Methods. Available from the International Electrotechnical Commission (IEC), 3 rue de
Current edition approved April 15, 2011. Published August 2011. Originally Varembe, Case postale 131, CH-1211 Geneva 20, Switzerland.
4
approved in 2002. Last previous edition approved in 2011 as F2182–11. DOI: Available from National Electrical Manufacturers Association (NEMA), 1300
10.1520/F2182-11A. N. 17th St., Suite 1752, Rosslyn, VA 22209, http://www.nema.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2182 − 11a
3.1.3 isocenter—geometric center of the gradient coil phantom material is a gelled saline consisting of a saline
system, which ge
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
Designation:F2182–11 Designation:F2182–11a
Standard Test Method for
Measurement of Radio Frequency Induced Heating On or
Near Passive Implants During Magnetic Resonance
1
Imaging
This standard is issued under the fixed designation F2182; 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. Scope
1.1 This test method covers measurement of radio frequency (RF) induced heating on or near a passive medical implant and
its surroundings during magnetic resonance imaging (MRI).
1.2 This test method is one of those required to determine if the presence of a passive implant may cause injury to the patient
with the implant during an MR procedure. Other safety issues that should be addressed include magnetically induced displacement
force and torque, as well as proper device function while in various configurations in the MR environment.
1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency,
which is dependent on the static magnetic field strength of the MR system. Because of possible additional heating, particularly
when implant dimensions approaches or exceeds one quarter of the wavelength of the RF field inside the phantom, conclusions
frommeasurementsmadeatonestaticmagneticfieldstrengthdonotapplytootherfieldstrengthsandfrequencies.Whilethefocus
in this test method is on 1.5 Tesla (T) or 3 Tesla cylindrical bore MR systems, the RF-induced temperature rise for an implant in
open MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the
method described herein.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body. For other implantation
conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes),
modifications of this test method are necessary.
1.5 This test method applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of the IEC Standard
60601-2-33, Ed. 2.0, with a whole body RF transmit coil as defined in section 2.2.100. The RF coil is assumed to have quadrature
excitation.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
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 IEC Standard:
60601-2-33, Ed. 2.0 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Magnetic Resonance
Equipment for Medical Diagnosis, 2002
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 March 1,April 15, 2011. Published MarchAugust 2011. Originally approved in 2002. Last previous edition approved in 20092011 as
F2182–09.F2182 – 11. DOI: 10.1520/F2182-11A.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 the International Electrotechnical Commission (IEC), 3 rue de Varembe, Case postale 131, CH-1211 Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F2182–11a
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2.3 NEMA Standard:
NEMA MS 8—2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging
...
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