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ASTM F2119-07(2013)

(Test Method)

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)

SIGNIFICANCE AND USE
5.1 This test method provides a quantified measure of the image artifact produced under a standard set of scanning conditions.  
5.2 This test method applies only to passive implants that have been established to be MR-Safe or MR-Conditional.
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 or MR-Conditional is excluded.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
WITHDRAWN RATIONALE
This test method characterized 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).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in March 2022 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
28-Feb-2013
Withdrawal Date
20-Mar-2022
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
Current Stage
Ref Project

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ASTM F2119-07(2013) - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)ASTM F2119-07(2013) - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)
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ASTM F2119-07(2013) - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 07 (Reapproved 2013)
Standard Test Method for
1
Evaluation of MR Image Artifacts from Passive Implants
This standard is issued under the fixed designation F2119; 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 3.1.3 magnetic resonance (MR) environment, n—volume
within the 0.50 mT(5 gauss (G)) line of an MR system, which
1.1 This test method characterizes the distortion and signal
includes the entire three dimensional volume of space sur-
lossartifactsproducedinamagneticresonance(MR)imageby
rounding the MR scanner. For cases where the 0.50 mT line is
a passive implant (implant that functions without the supply of
contained within the Faraday shielded volume, the entire room
electrical or external power). Anything not established to be
shall be considered the MR environment.
MR-Safe or MR-Conditional is excluded.
3.1.4 magnetic resonance imaging (MRI), n—imaging tech-
1.2 The values stated in SI units are to be regarded as
nique that uses static and time varying magnetic fields to
standard. No other units of measurement are included in this
provide images of tissue by the magnetic resonance of nuclei.
standard.
3.1.5 MR-Conditional, adj—an item that has been demon-
2. Referenced Documents
strated to pose no known hazards in a specified MR environ-
2
ment with specified conditions of use. Field conditions that
2.1 ASTM Standards:
define the specified MR environment include field strength,
F2052Test Method for Measurement of Magnetically In-
spatial gradient, dB/dt (time rate of change of the magnetic
duced Displacement Force on Medical Devices in the
field), radio frequency (RF) fields, and specific absorption rate
Magnetic Resonance Environment
(SAR).Additionalconditions,includingspecificconfigurations
F2182Test Method for Measurement of Radio Frequency
of the item, may be required.
Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging
3.1.6 MR-Safe, adj—anitemthatposesnoknownhazardsin
F2213Test Method for Measurement of Magnetically In-
all MR environments.
duced Torque on Medical Devices in the Magnetic Reso-
NOTE 1—MR-Safe items include nonconducting, nonmagnetic items
nance Environment
such as a plastic petri dish.An item may be determined to be MR-Safe by
F2503Practice for Marking Medical Devices and Other
providing a scientifically based rationale rather than test data.
Items for Safety in the Magnetic Resonance Environment
3.1.7 MR-Unsafe, adj—an item that is known to pose
hazards in all MR environments.
3. Terminology
NOTE 2—MR-Unsafe items include magnetic items such as a pair of
3.1 Definitions:
ferromagnetic scissors.
3.1.1 artifact width, n—the maximum distance (mm) from
3.1.8 tesla (T), n—theSIunitofmagneticinductionequalto
the edge of the implant to the fringe of the resulting image
4
10 G.
artifactfoundintheentiresetofimagesacquiredusingthistest
method.
4. Summary of Test Method
3.1.2 image artifact, n—apixelinanimageisconsideredto
4.1 Pairs of spin echo images are generated both with and
be part of an image artifact if the intensity is changed by at
without the implant in the field of view. Image artifacts are
least 30% when the device is present compared to a reference
assessed by computing differences outside the region corre-
image in which the device is absent.
spondingtotheimplantbetweenreferenceandimplantimages.
Once the worst case conditions using the spin echo pulse
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
sequence are ascertained, a pair of gradient echo images are
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
F04.15 on Material Test Methods.
acquired under the same conditions.
Current edition approved March 1, 2013. Published March 2013. Originally
approved in 2001. Last previous edition approved in 2007 as F2119–07. DOI:
5. Significance and Use
10.1520/F2119-07R13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1 This test method provides a quantified measure of the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
image artifact produced under a standard set of scanning
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. conditions.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2119 − 07 (2013)
5.2 This test method applies only to passive implants that may be used but a justification must be provided. Nickel
have been established to be MR-Safe or MR-Conditional.
...

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1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

  • Guide
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  • Guide
    8 pages
    English language
    sale 15% off