ASTM F2119-01

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

SCOPE
1.1 This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or external power). Anything not established to be MR-safe is excluded.

General Information

• Status: Historical
• Publication Date: 09-Jun-2001
• 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 F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• Effective Date: 01-Sep-2007
• Referred By: ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
• Effective Date: 10-Jun-2001
• Referred By: ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
• Effective Date: 10-Jun-2001
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 10-Jun-2001
• Referred By: ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 10-Jun-2001
• 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-Jun-2001
• 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-Jun-2001
• 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-Jun-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2119–01
Standard Test Method for
1
Evaluation of MR Image Artifacts from Passive Implants
This standard is issued under the fixed designation F 2119; 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 2.1.7 tesla(T),n—theSIunitofmagneticinductionequalto
4
10 G.
1.1 This test method characterizes the distortion and signal
loss artifacts produced in a magnetic resonance (MR) image by
3. Summary of Test Method
a passive implant (implant that functions without the supply of
3.1 Pairs of spin echo images are generated both with and
electrical or external power). Anything not established to be
without the implant in the field of view. Image artifacts are
MR-safe is excluded.
assessed by computing differences outside the region corre-
2. Terminology spondingtotheimplantbetweenreferenceandimplantimages.
Once the worst case conditions using the spin echo pulse
2.1 Definitions
sequence are ascertained, a pair of gradient echo images are
2.1.1 artifact width, n—the maximum distance (mm) from
acquired under the same conditions.
the edge of the implant to the fringe of the resulting image
artifactfoundintheentiresetofimagesacquiredusingthistest
4. Significance and Use
method.
4.1 This test method may be used to evaluate degree of MR
2.1.2 image artifact, n—a pixel in an image is considered to
compatibility for passive implants by providing a quantified
be part of an image artifact if the intensity is changed by at
measure of the image artifact produced under a standard set of
least 30 % when the device is present compared to a reference
scanning conditions.
image in which the device is absent.
4.2 This test method applies only to passive implants that
2.1.3 magnetic resonance (MR) environment, n—refers to
have been established to be MR-safe.
the electromagnetic environment present in the vicinity of an
MR system within the 5-G line.
5. Apparatus
2.1.4 magnetic resonance imaging (MRI), n—imaging tech-
5.1 AnMRimagingsystemwithastaticfieldstrengthof1.5
nique that uses static and time varying magnetic fields to
T is recommended. Alternatively, a different static field
provide images of tissue by the magnetic resonance of nuclei.
strength may be used and the measurements may be extrapo-
2.1.5 MR-safe, adj—the device, when used in the MR
lated to what would occur in a 1.5 T system, if a valid
environment, has been demonstrated to present no additional
extrapolationmethodisknown.TheMRIsystemmusthavethe
risk to the patient or other individuals, but may affect the
ability to swap readout and phase-encode directions.
quality of the diagnostic information. The MR conditions in
5.2 A reference object made from a nondistorting medium,
which the device was tested should be specified in conjunction
such as 0.5-in. diameter nylon rod.
with the term MR safe since a device which is safe under one
setofconditionsmaynotbefoundtobesoundermoreextreme
6. Test Specimen
MR conditions.
6.1 The implant for which image artifact is to be measured
2.1.6 MR-compatible, adj—the device, when used in the
shall serve as the test specimen.
MR environment, is MR-safe and has been demonstrated to
6.2 For the purposes of device qualification, the device
neither significantly affect the quality of the diagnostic infor-
evaluated according to this test method should be a finished
mation nor have its operations affected by the MR device. The
sterilized device.
MR conditions in which the device was tested should be
specified in conjunction with the term MR-compatible since a NOTE 1—The device does not have to be sterile at the time of testing;
however, it should have been subjected to all processing, packaging, and
devicewhichiscompatibleunderonesetofconditionsmaynot
sterilization steps before testing because any of these steps may affect the
be found to be so under more extreme MR conditions.
magnetic properties of the device.
6.3 This test method may be used on prototype devices at
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
any stage of production during product development. A justi-
and Surgical Materials and Devices and is the direct responsibility of subcommittee
fication for using a prototype instead of the finished device
F04.15 on Material Test Methods.
must be provided.
Current edition approved June 10, 2001. Published September 2001.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2119–01
7. Procedure 7.2.3 For images containing both the device being tested
and the reference o
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