ASTM F2182-02

Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

SCOPE
1.1 This test method covers measurement of Radio Frequency (RF) induced heating 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 person with the implant during an MRI procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque.
1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is proportional to the static magnetic field strength. Because of possible additional heating, particularly when device dimensions exceed a quarter wavelength, conclusions from measurements made at one frequency may not apply to other frequencies.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body.
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 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 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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2002
• 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 F2182-02a - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• Effective Date: 10-Nov-2002
• Referred By: ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 10-Apr-2002
• Referred By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
• Effective Date: 10-Apr-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-Apr-2002
• Referred By: ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
• Effective Date: 10-Apr-2002

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 2182 – 02
Standard Test Method for
Measurement of Radio Frequency Induced Heating Near
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Passive Implants During Magnetic Resonance Imaging
This standard is issued under the fixed designation F 2182; 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.
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1. Scope Magnetic Resonance Environment
F 2119 Test Method for Evaluation of MR Image Artifacts
1.1 This test method covers measurement of Radio Fre-
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from Passive Implants
quency (RF) induced heating near a passive medical implant
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2.2 IEC Standard:
and its surroundings during Magnetic Resonance Imaging
60601-2-33 Medical Electrical Equipment—Part 2: Particu-
(MRI).
lar Requirements for the Safety of Magnetic Resonance
1.2 This test method is one of those required to determine if
Equipment for Medical Diagnosis, 2001
the presence of a passive implant may cause injury to the
person with the implant during an MRI procedure. Other safety
3. Terminology
issues that should be addressed include magnetically induced
3.1 Definitions—For the purposes of this test method, the
displacement force and torque.
definitions in 3.1.1-3.1.8 shall apply.
1.3 The amount of RF-induced temperature rise for a given
3.1.1 isocenter—geometric center of the gradient coil sys-
specific absorption rate (SAR) will depend on the RF fre-
tem, which generally is the geometric center of a scanner with
quency, which is proportional to the static magnetic field
a cylindrical bore.
strength. Because of possible additional heating, particularly
3.1.2 magnetic resonance imaging (MRI)—diagnostic im-
when device dimensions exceed a quarter wavelength, conclu-
aging technique that uses static and time varying magnetic
sions from measurements made at one frequency may not
fields to provide images of tissue by the magnetic resonance of
apply to other frequencies.
nuclei.
1.4 This test method assumes that testing is done on devices
3.1.3 medical implant—a structure or device that is placed
that will be entirely inside the body.
within the body of the patient for medical diagnostic or
1.5 This test method applies to whole body magnetic
therapeutic purposes.
resonance equipment, as defined in section 2.2.103 of the IEC
3.1.4 MR safe—the device, when used in the MR environ-
Standard 60601-2-33 with a whole body RF transmit coil as
ment, has been demonstrated to present no additional risk to
defined in section 2.2.100. The RF coil is assumed to have
the patient or other individuals, but may affect the quality of
quadrature excitation.
the diagnostic information. The MR conditions in which the
1.6 This standard does not purport to address all of the
device was tested should be specified in conjunction with the
safety concerns, if any, associated with its use. It is the
terms MR safe and MR compatible since a device which is safe
responsibility of the user of this standard to establish appro-
or compatible under one set of conditions may not be found to
priate safety and health practices and determine the applica-
be so under more extreme MR conditions.
bility of regulatory limitations prior to use.
3.1.5 MR compatible—the device, when used in the MR
2. Referenced Documents environment, is MR safe and has been demonstrated to neither
significantly affect the quality of the diagnostic information nor
2.1 ASTM Standards:
have its operations affected by the MR device. The MR
A 340 Terminology of Symbols and Definitions Relating to
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conditions in which the device was tested should be specified
Magnetic Testing
in conjunction with the terms MR safe and MR compatible
F 2052 Test Method for Measurement of Magnetically In-
since a device which is safe or compatible under one set of
duced Displacement Force on Passive Implants in the
conditions may not be found to be so under more extreme MR
conditions.
3.1.6 passive implant—an implant that serves its function
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This test method is under the jurisdiction of ASTM Committee F04 on Medical
without supply of electrical power.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
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Current edition approved Apr. 10, 2002. Published June 2002. Annual Book of ASTM Standards, Vol 13.01.
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Annual Book of ASTM Standards, Vol 03.04. 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.
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