ASTM_F_2182_-_11a.pdf

Designation:F218211aStandard Test Method forMeasurement of Radio Frequency Induced Heating On orNear Passive Implants During Magnetic ResonanceImaging1This standard is issued under the fixed designation F2182;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers measurement of radio fre-quency(RF)induced heating on or near a passive medicalimplant and its surroundings during magnetic resonance imag-ing(MRI).1.2 This test method is one required to determine if thepresence of a passive implant may cause injury to the patientwith the implant during an MR procedure.Other safety issuesthat should be addressed include magnetically induced dis-placement force and torque,as well as proper device functionwhile in various configurations in the MR environment.1.3 The amount of RF-induced temperature rise for a givenspecific absorption rate(SAR)will depend on the RFfrequency,which is dependent on the static magnetic fieldstrength of the MR system.While the focus in this test methodis on 1.5 Tesla(T)or 3 Tesla cylindrical bore MR systems,theRF-induced temperature rise for an implant in MR systems ofother static magnetic field strengths or magnet designs can beevaluated by suitable modification of the method describedherein.1.4 This test method assumes that testing is done on devicesthat will be entirely inside the body.For other implantationconditions(for example,external fixation devices,percutane-ous needles,catheters or tethered devices such as ablationprobes),modifications of this test method are necessary.1.5 This test method applies to whole body magneticresonance equipment,as defined in section 2.2.103 of the IECStandard 60601-2-33,Ed.2.0,with a whole body RF transmitcoil as defined in section 2.2.100.The RF coil is assumed tohave quadrature excitation.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F2052 Test Method for Measurement of Magnetically In-duced Displacement Force on Medical Devices in theMagnetic Resonance EnvironmentF2119 Test Method for Evaluation of MR Image Artifactsfrom Passive ImplantsF2213 Test Method for Measurement of Magnetically In-duced Torque on Medical Devices in the Magnetic Reso-nance EnvironmentF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance Environment2.2 IEC Standard:360601-2-33,Ed.2.0 Medical Electrical EquipmentPart 2:Particular Requirements for the Safety of Magnetic Reso-nance Equipment for Medical Diagnosis,20022.3 NEMA Standard:4NEMA MS 82008 Characterization of the Specific Ab-sorption Rate for Magnetic Resonance Imaging Systems3.Terminology3.1 Definitions:3.1.1 gelled salinephantom medium consisting of sodiumchloride and polyacrylic acid or sodium chloride and hydroxy-ethylcellulose in water as specified in this test method.3.1.2 implant,nin medicine,an object,structure,or deviceintended to reside within the body for diagnostic,prosthetic,orother therapeutic purposes.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved April 15,2011.Published August 2011.Originallyapproved in 2002.Last previous edition approved in 2011 as F2182 11.DOI:10.1520/F2182-11A.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from the International Electrotechnical Commission(IEC),3 rue deVarembe,Case postale 131,CH-1211 Geneva 20,Switzerland.4Available from National Electrical Manufacturers Association(NEMA),1300N.17th St.,Suite 1752,Rosslyn,VA 22209,http:/www.nema.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.3 isocentergeometric center of the gradient coilsystem,which generally is the geometric center of a scannerwith a cylindrical bore.3.1.4 local SARspecific absorption rate(SAR)averagedover any 10 g of tissue of the patient body and over a specifiedtime.60601-2-33,Ed.2.03.1.5 magnetic resonance(MR)environmentvolumewithin the 0.50 mT(5 gauss(G)line of an MR system,whichincludes the entire three dimensional volume of space sur-rounding the MR scanner.For cases where th