ASTM_F_2052_-_15.pdf

Designation:F205215Standard Test Method forMeasurement of Magnetically Induced Displacement Forceon Medical Devices in the Magnetic ResonanceEnvironment1This standard is issued under the fixed designation F2052;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 the measurement of the mag-netically induced displacement force produced by static mag-netic field gradients on medical devices and the comparison ofthat force to the weight of the medical device.1.2 This test method does not address other possible safetyissues which include but are not limited to issues of magneti-cally induced torque,RF heating,induced heating,acousticnoise,interaction among devices,and the functionality of thedevice and the MR system.1.3 This test method is intended for devices that can besuspended from a string.Devices which cannot be suspendedfrom a string are not covered by this test method.The weightof the string from which the device is suspended during the testmust be less than 1%of the weight of the tested device.1.4 This test method shall be carried out in a horizontal boreMR system with a static magnetic filed oriented horizontallyand parallel to the MR system bore.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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 requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2F2119 Test Method for Evaluation of MR Image Artifactsfrom Passive ImplantsF2182 Test Method for Measurement of Radio FrequencyInduced Heating On or Near Passive Implants DuringMagnetic Resonance ImagingF2213 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 Other Standards:3IEC 60601233 Ed.2.0 Medical Electronic EquipmentPart 2:Particular Requirements for the Safety of MagneticResonance Equipment for Medical DiagnosisISO 13485:2003(E)Medical DevicesQuality Manage-ment SystemsRequirements for Regulatory Purposes,definition 3.7ISO 14971 Medical devices-Application of risk manage-ment to medical devices3.Terminology3.1 Definitions:3.1.1 diamagnetic material,na material whose relativepermeability is less than unity.3.1.2 ferromagnetic material,na material whose magneticmoments are ordered and parallel producing magnetization inone direction.3.1.3 magnetic field strength(H in A/m),nstrength of theapplied magnetic field.3.1.4 magnetic induction or magnetic flux density(B in T),nthat magnetic vector quantity which at any point in amagnetic field is measured either by the mechanical forceexperienced by an element of electric current at the point,or bythe electromotive force induced in an elementary loop duringany change in flux linkages with the loop at the point.Themagnetic induction is frequently referred to as the magnetic1This 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 Sept.15,2015.Published September 2015.Originallyapproved in 2000.Last previous edition approved in 2014 as F2052 14.DOI:10.1520/F2052-15.2For 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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 field.Bois the static field in a MR system.Plain type indicatesa scalar(for example,B)and bold type indicates a vector(forexample,B).3.1.5 magnetic resonance diagnostic device,na deviceintended for general diagnostic use to present images whichreflect the spatial distribution or magnetic resonance spectra,orboth,which reflect frequency and distribution of nuclei exhib-iting nuclear magnetic resonance.Other physical parametersderived from the images or spectra,or both,may also beproduced.3.1.6 magnetic resonance(MR)environment,nvolumewithin 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 the 0.50 mT line iscontained within the Faraday shielded volume,the entire rooms