ASTM F2182-19
(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
5.1 This test method describes a test procedure for evaluating the ∆T associated with RF emitted during MR procedures, involving a specific frequency of RF irradiation of an implant. The method allows characterization of the heating propensity of the implant rather than the prediction of heating during a specific MR procedure in patients.
5.2 The results may be used as an input to a computational model for estimating ∆T 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 within a phantom during magnetic resonance imaging (MRI). The test method does not specify levels of heating considered to be safe to the patient and relies on users to define their own acceptance criteria.
1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced-displacement, magnetically-induced torque, image artifact, acoustic noise, tissue heating, interaction among devices, and the functionality of the device and the MR system.
1.3 The amount of RF-induced temperature rise (∆T) for a given incident electric field 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 T MR systems, the ∆T 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. Testing for devices with other implantation conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes) is beyond the scope of this standard; for such devices, modifications of this test method may be necessary.
Note 1: RF-heating induced by any electrically conductive implanted device may be impacted by the presence of other metallic or otherwise electrically conductive devices present nearby.
1.5 This test method is written for several possible RF exposure systems, including Volume RF transmit coils. The exposure system needs to be properly characterized, within the stated uncertainties, in term of local background RF exposure for the implants which are tested.
1.6 The values stated in SI units are to be regarded as standard.
1.7 A device with deployed dimensions of less than 2 cm in all directions does not need to be tested with respect to RF-induced heating, as it is expected to generate ∆T of less than 2°C over 1 hour of exposure at 1.5 T and 3 T frequencies (1, 22 and ANSI/AAMI/ISO 14708-3:2017). This condition is not valid when multiple replicas of the device (for example, multiple anchors) are implanted within 3 cm of the device.
Note 2: The above values were derived from existing data and literature. The 3 cm distance is recommended to avoid any RF coupling with other neighboring devices.
1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation: F2182 − 19
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 stated uncertainties, in term of local background RF exposure
for the implants which are tested.
1.1 This test method covers measurement of radio fre-
quency (RF)-induced heating on or near a passive medical 1.6 The values stated in SI units are to be regarded as
implant within a phantom during magnetic resonance imaging standard.
(MRI). The test method does not specify levels of heating
1.7 Adevice with deployed dimensions of less than 2 cm in
consideredtobesafetothepatientandreliesonuserstodefine
all directions does not need to be tested with respect to
their own acceptance criteria.
RF-induced heating, as it is expected to generate �T of less
1.2 This test method does not address other possible safety than 2°C over 1 hour of exposure at 1.5 T and 3 T frequencies
2
issues which include but are not limited to issues of magneti- (1, 2 and ANSI/AAMI/ISO 14708-3:2017). This condition is
cally induced-displacement, magnetically-induced torque, im- not valid when multiple replicas of the device (for example,
age artifact, acoustic noise, tissue heating, interaction among multiple anchors) are implanted within 3 cm of the device.
devices,andthefunctionalityofthedeviceandtheMRsystem.
NOTE 2—The above values were derived from existing data and
literature. The 3 cm distance is recommended to avoid any RF coupling
1.3 The amount of RF-induced temperature rise (�T) for a
with other neighboring devices.
given incident electric field will depend on the RF frequency,
1.8 This standard does not purport to address all of the
which is dependent on the static magnetic field strength of the
safety concerns, if any, associated with its use. It is the
MR system. While the focus in this test method is on 1.5 tesla
responsibility of the user of this standard to establish appro-
(T) or 3 T MR systems, the �T for an implant in MR systems
priate safety, health, and environmental practices and deter-
of other static magnetic field strengths or magnet designs can
mine the applicability of regulatory limitations prior to use.
be evaluated by suitable modification of the method described
1.9 This international standard was developed in accor-
herein.
dance with internationally recognized principles on standard-
1.4 Thistestmethodassumesthattestingisdoneondevices
ization established in the Decision on Principles for the
that will be entirely inside the body. Testing for devices with
Development of International Standards, Guides and Recom-
other implantation conditions (for example, external fixation
mendations issued by the World Trade Organization Technical
devices, percutaneous needles, catheters or tethered devices
Barriers to Trade (TBT) Committee.
such as ablation probes) is beyond the scope of this standard;
for such devices, modifications of this test method may be
2. Referenced Documents
necessary.
3
2.1 ASTM Standards:
NOTE 1—RF-heating induced by any electrically conductive implanted
B348Specification for Titanium and Titanium Alloy Bars
device may be impacted by the presence of other metallic or otherwise
and Billets
electrically conductive devices present nearby.
F2052Test Method for Measurement of Magnetically In-
1.5 This test method is written for several possible RF
duced Displacement Force on Medical Devices in the
exposure systems, including Volume RF transmit coils. The
Magnetic Resonance Environment
exposuresystemneedstobeproperlycharacterized,withinthe
1 2
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical The boldface numbers in parentheses refer to a list of references at the end of
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee this standard.
3
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 15, 2019. Published October 2019. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2002. Last previous edition approved in 2011 as F2182–11a. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2182-19. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2182 − 19
F2213Test Method for Measurement of Mag
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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.
Designation: F2182 − 11a F2182 − 19
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 (RF)-induced heating on or near a passive medical
implant and its surroundingswithin a phantom during magnetic resonance imaging (MRI). The test method does not specify levels
of heating considered to be safe to the patient and relies on users to define their own acceptance criteria.
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.does not address other
possible safety issues which include but are not limited to issues of magnetically induced-displacement, magnetically-induced
torque, image artifact, acoustic noise, tissue heating, interaction among devices, and the functionality of the device and the MR
system.
1.3 The amount of RF-induced temperature rise (T) for a given specific absorption rate (SAR) incident electric field 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 Teslatesla (T) or 3 Tesla cylindrical bore T MR systems, the RF-inducedT 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 Testing for devices with
other implantation conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as
ablation probes), probes) is beyond the scope of this standard; for such devices, modifications of this test method are may be
necessary.
NOTE 1—RF-heating induced by any electrically conductive implanted device may be impacted by the presence of other metallic or otherwise
electrically conductive devices present nearby.
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.is written for several possible RF exposure systems, including Volume RF transmit coils. The exposure system needs
to be properly characterized, within the stated uncertainties, in term of local background RF exposure for the implants which are
tested.
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 A device with deployed dimensions of less than 2 cm in all directions does not need to be tested with respect to RF-induced
2
heating, as it is expected to generateT of less than 2°C over 1 hour of exposure at 1.5 T and 3 T frequencies (1, 2 and
ANSI/AAMI/ISO 14708-3:2017). This condition is not valid when multiple replicas of the device (for example, multiple anchors)
are implanted within 3 cm of the device.
NOTE 2—The above values were derived from existing data and literature. The 3 cm distance is recommended to avoid any RF coupling with other
neighboring 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 15, 2011Sept. 15, 2019. Published August 2011October 2019. Originally approved in 2002. Last previous edition approved in 2011 as
F2182 – 11.F2182 – 11a. DOI: 10.1520/F2182-11A.10.1520/F2182-19.
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2182 −
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