ASTM_F_2503_-_13.pdf

Designation:F250313Standard Practice forMarking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment1This standard is issued under the fixed designation F2503;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 international standard applies to the practice ofmarking of items that might be used in the magnetic resonance(MR)environment.1.2 The purpose of this practice is to mark items that mightbe brought into the MR environment and to recommendinformation that should be included in the marking.1.3 The standard specifies the permanent marking of items,which are used in an MR environment,by means of terms andicons.1.4 MR image artifacts are not considered to be a perfor-mance issue and so are not addressed in this internationalstandard practice(see X1.5).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 limitations prior to use.2.Referenced Documents2.1 The following referenced documents are indispensablefor the application of this document.For dated references,onlythe edition cited applies.For undated references,the latestedition of the referenced document(including any amend-ments)applies.2.2 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 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 Environment2.3 Other Standards:IEC 60601-2-33 Medical Electrical EquipmentPart 2-33:Particular Requirements for the Safety of Magnetic Reso-nance Equipment for Medical Diagnosis3ISO 14971 Medical DevicesApplication of Risk Manage-ment to Medical Devices4ISO/IEC Guide 51 Safety AspectsGuidelines for theirInclusion in Standards4ISO TS 10974 Assessment of the Safety of Magnetic Reso-nance Imaging for Patients with an Active ImplantableMedical Device43.Terminology3.1 Definitions:3.1.1 harmful interactionunintended direct or indirect in-teraction of items with MR equipment,especially with thestatic magnetic field,the gradient fields and the RF fields of theMR equipment,that can pose hazards to patients or otherpersons.NOTE1In this context,the affected image quality or image artifactsare not considered to be a harmful interaction.3.1.2 hazardpotential source of harm.ISO/IEC Guide 513.1.3 itemobject that might be brought into the MRenvironment.3.1.4 magnetically induced displacement forceforce pro-duced when a magnetic object is exposed to the spatial gradient1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved June 1,2013.Published July 2013.Originally approvedin 2005.Last previous edition approved in 2008 as F250308.DOI:10.1520/F2503-13.2For 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 International Electrotechnical Commission(IEC),3,rue deVaremb,P.O.Box 131,CH-1211 Geneva 20,Switzerland,http:/www.iec.ch.4Available 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 of a static magnetic field.This force will tend to cause theobject to translate in the spatial gradient of the static magneticfield.3.1.5 magnetically induced torquetorque produced whena magnetic object is exposed to a magnetic field.This torquewill tend to cause the object to align itself along the magneticfield in an equilibrium direction that induces no torque.3.1.6 magnetic induction or magnetic flux density(B inT)that 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 magneticfield.B0is the static fie