ASTM F2119-2007 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants《评定被动植入物MR图象制品的标准试验方法》.pdf
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1、Designation: F 2119 07Standard Test Method forEvaluation of MR Image Artifacts from Passive Implants1This standard is issued under the fixed designation F 2119; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis
2、ion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method characterizes the distortion and signalloss artifacts produced in a magnetic resonance (MR) image bya passive
3、implant (implant that functions without the supply ofelectrical or external power). Anything not established to beMR-Safe or MR-Conditional is excluded.2. Referenced Documents2.1 ASTM Standards:2F 2052 Test Method for Measurement of Magnetically In-duced Displacement Force on Medical Devices in theM
4、agnetic Resonance EnvironmentF 2182 Test Method for Measurement of Radio FrequencyInduced Heating Near Passive Implants During MagneticResonance ImagingF 2213 Test Method for Measurement of Magnetically In-duced Torque on Medical Devices in the Magnetic Reso-nance EnvironmentF 2503 Practice for Mark
5、ing Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment3. Terminology3.1 Definitions3.1.1 artifact width, nthe maximum distance (mm) fromthe edge of the implant to the fringe of the resulting imageartifact found in the entire set of images acquired using this testmethod.3
6、.1.2 image artifact, na pixel in an image is considered tobe part of an image artifact if the intensity is changed by atleast 30 % when the device is present compared to a referenceimage in which the device is absent.3.1.3 magnetic resonance (MR) environment, nvolumewithin the 0.50 mT (5 gauss (G) l
7、ine of an MR system, whichincludes the entire three dimensional volume of space sur-rounding the MR scanner. For cases where the 0.50 mT line iscontained within the Faraday shielded volume, the entire roomshall be considered the MR environment.3.1.4 magnetic resonance imaging (MRI), nimaging tech-ni
8、que that uses static and time varying magnetic fields toprovide images of tissue by the magnetic resonance of nuclei.3.1.5 MR-Conditional, adjan item that has been demon-strated to pose no known hazards in a specified MR environ-ment with specified conditions of use. Field conditions thatdefine the
9、specified MR environment include field strength,spatial gradient, dB/dt (time rate of change of the magneticfield), radio frequency (RF) fields, and specific absorption rate(SAR).Additional conditions, including specific configurationsof the item, may be required.3.1.6 MR-Safe, adjan item that poses
10、 no known hazardsin all MR environments.NOTE 1MR-Safe items include nonconducting, nonmagnetic itemssuch as a plastic petri dish. An item may be determined to be MR-Safe byproviding a scientifically based rationale rather than test data.3.1.7 MR-Unsafe, adjan item that is known to posehazards in all
11、 MR environments.NOTE 2MR-Unsafe items include magnetic items such as a pair offerromagnetic scissors.3.1.8 tesla (T), nthe SI unit of magnetic induction equal to104G.4. Summary of Test Method4.1 Pairs of spin echo images are generated both with andwithout the implant in the field of view. Image art
12、ifacts areassessed by computing differences outside the region corre-sponding to the implant between reference and implant images.Once the worst case conditions using the spin echo pulsesequence are ascertained, a pair of gradient echo images areacquired under the same conditions.5. Significance and
13、 Use5.1 This test method provides a quantified measure of theimage artifact produced under a standard set of scanningconditions.1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of subcommitteeF04.15 on Mat
14、erial Test Methods.Current edition approved Sept. 1, 2007. Published September 2007. Originallyapproved in 2001. Last previous edition approved in 2001 as F 2119 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Bo
15、ok of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2 This test method applies only to passive implants thathave been established t
16、o be MR-Safe or MR-Conditional.6. Apparatus6.1 An MR imaging system with a static field strength of 1.5T or 3.0 T is recommended. The MRI system must have theability to swap readout and phase-encode directions.6.2 A reference object made from a nondistorting medium,such as 0.5-in. diameter nylon rod
17、.7. Test Specimen7.1 The implant for which image artifact is to be measuredshall serve as the test specimen.7.2 For the purposes of device qualification, the deviceevaluated according to this test method should be a finishedsterilized device.NOTE 3The device does not have to be sterile at the time o
18、f testing;however, it should have been subjected to all processing, packaging, andsterilization steps before testing because any of these steps may affect themagnetic properties of the device.7.3 This test method may be used on prototype devices atany stage of production during product development.
19、A justi-fication for using a prototype instead of the finished devicemust be provided.8. Procedure8.1 MR Imaging Parameters for Testing Artifacts:8.1.1 The recommended MR imaging test environment forevaluation of artifacts are given as follows. An alternative maybe used if an adequate case can be ma
20、de for relevance to thespecific device. Field of view, slice thickness, and matrix sizeshall be adjusted to achieve pixel dimensions to accuratelymeasure the artifact. Two example situations are described, onefor small implants, such as a coronary stent, and one for largerimplants such as an artific
21、ial hip joint.Static field strength: 1.5T (see 6.1)Bandwidth: 32 kHz (required)Field of view: sufficient to encompass the entire implantand the artifactSmall implant (for example, coronary stent):Matrix size: 256 3 256Slice thickness: 3 mmLarge implant (for example, hip implant):Matrix size: 256 3 1
22、28Slice thickness: 5 mmTwo different pulse sequences will be used:Pulse sequence: spin echoTR: 500 msTE: 20 msPulse sequence: gradient echoTR: 100 500 msTE: 15 msFlip angle: 308.1.2 The device should be immersed in a solution. Forexample, a copper sulfate (CuSO4) solution (12 g/L) may beused to redu
23、ce T1and keep TR at a reasonable level. Thedevice may be suspended in nylon netting. If a copper sulfatesolution is inappropriate for a particular device, a substitutemay be used but a justification must be provided. Nickelchloride (NiCl2) and manganese chloride (MnCl2) are possiblesubstitutes. To a
24、chieve adequate field homogeneity, thereshould be at least 4 cm of clearance between the device andeach side of the container holding the solution and the implant.8.1.3 Each image must contain a reference object, (made ofnylon or some other material, which does not cause distortion),so that the posi
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