ASTM F2503-2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment《用于保证磁共振环境安全的医疗器械及其他项标记的标准实施规程》.pdf

《ASTM F2503-2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment《用于保证磁共振环境安全的医疗器械及其他项标记的标准实施规程》.pdf》由会员分享，可在线阅读，更多相关《ASTM F2503-2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment《用于保证磁共振环境安全的医疗器械及其他项标记的标准实施规程》.pdf（9页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F2503 13Standard 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 revi

2、sion, 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 mag

3、netic 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

4、 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 standar

5、d 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

6、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

7、 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 Imaging

8、F2213 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

9、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 h

10、armful 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.NOTE 1In this context, the affected image quality or image ar

11、tifactsare 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 practi

12、ce 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 200

13、8 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 Internati

14、onal 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,

15、PO Box C700, West Conshohocken, PA 19428-2959. United States1of 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. Thi

16、s 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 forceexpe

17、rienced 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 field in an MR equipment and accessor

18、ies.Plain type indicates a scalar (for example, B) and bold typeindicates a vector (for example, B).3.1.7 magnetic resonance (MR)resonant absorption ofelectromagnetic energy by an ensemble of atomic nucleisituated in a magnetic field. IEC 60601-2-33, definition201.3.2173.1.8 magnetic resonance (MR)

19、equipmentmedical elec-trical equipment which is intended for in vivo magneticresonance examination of a patient comprising all parts inhardware and software from the supply mains to the displaymonitor.NOTE 2The MR equipment is a programmable electrical medicalsystem (PEMS). IEC 60601-2-33, definitio

20、n 201.3.2183.1.9 magnetic resonance (MR) examinationprocess ofacquiring data by magnetic resonance from a patient. IEC60601-2-33, definition 201.3.2193.1.10 magnetic resonance (MR) environmentthe threedimensional volume of space surrounding the MR magnet thatcontains both the Faraday shielded volume

21、 and the 0.50 mTfield contour (5 gauss (G) line). This volume is the region inwhich an item might pose a hazard from exposure to theelectromagnetic fields produced by the MR equipment andaccessories.3.1.11 MR Conditionalan item with demonstrated safetyin the MR environment within defined conditions.

22、 At aminimum, address the conditions of the static magnetic field,the switched gradient magnetic field and the radiofrequencyfields. Additional conditions, including specific configurationsof the item, may be required.3.1.12 Supplementary Markingadditional informationthat, in association with a mark

23、ing as “MR Conditional,” statesvia additional language the conditions in which an item can beused safely within the MR environment.3.1.13 MR Safean item that poses no known hazardsresulting from exposure to any MR environment. MR Safeitems are composed of materials that are electricallynonconductive

24、, nonmetallic, and nonmagnetic.NOTE 3An item composed entirely of electrically nonconductive,nonmetallic and nonmagnetic materials may be determined to be MR Safeby providing a scientifically based rationale rather than test data. Ex-amples of MR Safe items are a cotton blanket or a silicone cathete

25、r.3.1.14 MR Unsafean item which poses unacceptable risksto the patient, medical staff or other persons within the MRenvironment.NOTE 4ISO 14971 Medical devicesApplication of risk managementto medical devices, includes a process for evaluating risks, includingidentifying unacceptable risks. MR Unsafe

26、 items include items such as apair of ferromagnetic scissors.3.1.15 medical deviceany instrument, apparatus,implement, machine, appliance, implant, in vitro reagent orcalibrator, software, material, or other similar or related article,intended by the manufacturer to be used, alone or incombination,

27、for human beings for one or more of the specificpurpose(s) of:(1) diagnosis, prevention, monitoring, treatment, or allevia-tion of disease,(2) diagnosis, monitoring, treatment, alleviation of, or com-pensation for an injury,(3) investigation, replacement, modification, or support ofthe anatomy or of

28、 a physiological process,(4) supporting or sustaining life,(5) control of conception,(6) disinfection of medical devices,(7) providing information for medical purposes by meansof in vitro examination of specimens derived from the humanbody, and which does not achieve its primary intended actionin or

29、 on the human body by pharmacological, immunological,or metabolic means, but which may be assisted in its functionby such means. ISO 134853.1.16 radio frequency (RF) magnetic fieldthe magneticfield in MRI that is used to flip the magnetic moments. Thefrequency of the RF field is B0where is the gyrom

30、agneticconstant, 42.56 MHz/T for protons, and B0is the staticmagnetic field in Tesla.3.1.17 safetyfreedom from unacceptable risk.3.1.18 specific absorption rate (SAR)radio frequencypower absorbed per unit of mass (W/kg). IEC 60601-2-333.1.19 tesla, (T)the SI unit of magnetic induction equal to104gau

31、ss (G).4. Significance and Use4.1 Interactions of medical devices and other items with theMR environment has resulted in serious injuries and death ofpatients and other individuals. Additionally, hazards stemmingfrom equipment malfunction are of concern. Section 4.2 listspossible direct and indirect

32、 causes of hazards in the MRenvironment.4.2 Potential direct and indirect causes of hazards:4.2.1 Direct causes:4.2.1.1 mechanical causes, including magnetically induceddisplacement force, torque, and vibration4.2.1.2 electromagnetic causes, including induction(heating, stimulation) and discharge (s

33、park gap)4.2.1.3 acoustic causes4.2.2 Indirect causes:4.2.2.1 malfunction of items, for example of vital compo-nents such as valves, monitors and pumpsF2503 1324.3 This practice provides a uniform system for marking toindicate the conditions for which it has been determined that amedical device or o

34、ther item may be safely placed and used inthe MR environment. It provides simple visual icons and termswhich are intended to reduce injuries and other mishaps thatoccur when items that pose hazards in the MR environment arebrought into the MR environment.5. Requirements for Assessment of Potential H

35、azardsCaused by Interactions of an Item and the MREnvironment5.1 Perform testing sufficient to characterize the behavior ofthe item in the MR environment.5.1.1 In particular, testing for items that may be placed inthe MR environment should address magnetically induceddisplacement force (Test Method

36、F2052), magnetically in-duced torque (Test Method F2213), and RF heating (TestMethod F2182 for passive implants and ISO TS 10974 foractive implants). Additionally, electronic components shall beevaluated for malfunction.5.1.2 Other possible safety issues to consider for the hazardassessment include,

37、 but are not limited to, thermal injury,induced currents/voltages, interaction with the switched gradi-ent field (dB/dt) for all items that may go inside the magnetbore, electromagnetic compatibility, neurostimulation, acousticnoise, interaction among devices, and the malfunction of theitem and the

38、malfunction of the MR equipment and accesso-ries. See Table X1.1 for some hazards and associated testmethods. Also see section X1.2.1.4.5.2 List any parameter that affects the safety of the item.Describe any condition that is known to produce an unsafecondition.NOTE 5These remarks do not claim to be

39、 complete. Therefore it isrecommended that the user of this standard consider specific questions andtopics that may be applicable to the specific item being evaluated. Somepotential hazards to patients and others in the MR environment are givenin X1.2.1 and Table X1.1.6. Methods of Marking6.1 The ma

40、rking method shall not compromise performanceor function of the marked item and should provide legibilityover the anticipated service life of the item. For all itemsexternal to the body of a person for which it is technicallyfeasible, labeling for MR Conditional items shall appear on theitem and inc

41、lude the conditions for safety in the MR environ-ment.7. Information Included in MR Marking7.1 Medical devices and other items vary widely in size, andthe amount of information that practically can be included inmarking varies accordingly. For implants, the MR markingshall be included in the labelin

42、g (including the instructions foruse, package inserts, patient and physician manuals) and on thepatient information card. Non-implanted items, where feasible,shall have MR marking on the item as well as in the labeling.Some items (for example, small or very thin ones) do notprovide any surfaces whic

43、h can be marked practically. Foritems for which direct marking is not practical, the MRmarking shall be included in the labeling. For both implantsand non-implanted items, the MR marking may be placed onthe product packaging label (e.g. on the box), however thepackage label should clearly indicate t

44、he item(s) inside thepackaging to which the MR marking applies (e.g., implant onlyor implant and delivery system).7.2 The marking method shall not compromise performanceor function of the marked item and should remain readableover the anticipated service life of the item.7.3 Minimum InformationAs a

45、result of the testing de-scribed in Section 5, mark the item as MR Safe, MRConditional, or MR Unsafe using the icons as shown in Tables1 and 2.7.3.1 The MR Safe icon consists of the letters “MR”surrounded by a green square (Table 1 and Figures 1 and 2).Two options are given. When color reproduction

46、is notpractical, the icon may be printed in black and white (Table 2and Figures 3 and 4). The use of the colored icon is stronglyencouraged for the added visibility and information providedby the color. For both color and black and white options inTables 1 and 2, the option that is most visible for

47、the individualapplication should be chosen.7.3.2 The MR Conditional icon consists of the letters “MR”within a yellow equilateral triangle with a thick black bandaround the perimeter (Table 1 and Figure 5). The triangle isoriented with its horizontal side below the letters “MR.” Whencolor reproductio

48、n is not practical, the icon may be printed inblack and white (Table 2 and Figure 6). The use of the coloredicon is strongly encouraged for the added visibility andinformation provided by the color.7.3.2.1 For MR Conditional items, the item labeling (in-structions for use, package inserts, operator

49、manual, patientTABLE 1 Requirements for Colored MR IconsIcon Geometric Shape and Appearance MeaningA squareMR SafeorAn equilateral triangle with radiused outercornersMR ConditionalA circle with a diagonal barMR UnsafeF2503 133information card, patient and physician information pamphlets,as appropriate) shall include appropriate information fromSection 5.(1) The MR Conditional icon may be supplemented bysupplementary marking which includes the appropriate infor-mation from Section 5 and describes the conditions for whichthe item has been demonstrat