ASTM F2503-2005 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment《磁共振环境下医疗装置和其他元件的安全标记的标准实施规程》.pdf

1、Designation: F 2503 05Standard Practice forMarking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment1This standard is issued under the fixed designation F 2503; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re

2、vision, the year of last revision. 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 practice covers the marking of medical devices andother items to indicate their safety in th

3、e magnetic resonance(MR) environment.1.2 The purpose of this practice is to (1) recommend thatitems that may be brought into the MR environment bepermanently marked to indicate the MR environment to whicha specific item may safely be exposed, and (2) recommendinformation that should be included in t

4、he marking. It isrecognized that direct marking on the item is not practical forimplants and certain other medical devices. Where directmarking is not practical, this practice recommends that themarking be included in the labeling and on patient informationcards (see 7.1).1.3 Image artifact is not c

5、onsidered to be a safety issue andso is not addressed in this practice (see X1.5).1.4 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 d

6、etermine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F 2052 Test Method for Measurement of Magnetically In-duced Displacement Force on Medical Devices in theMagnetic Resonance EnvironmentF2119 Test Method for Evaluation of MR Image Artifactsfr

7、om Passive ImplantsF 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 Environment2.2 Other Standards:ISO 3864-1:200

8、2(E) Graphical SymbolsSafety Coloursand Safety SignsPart 1: Design Principles for SafetySigns in Workplaces and Public Areas3ISO 13485:2003(E) Medical DevicesQuality Manage-ment SystemsRequirements for Regulatory Purposes,definition 3.73ISO/IEC Guide 51:1999, definition 3.54IEC 60601-2-33, Ed. 2.0 M

9、edical Electrical EquipmentPart 2: Particular Requirements for the Safety of MagneticResonance Equipment for Medical Diagnosis43. Terminology3.1 Definitions:3.1.1 hazardpotential source of harm. ISO/IECGuide 513.1.2 itemmedical device or other object that may bebrought into the MR environment.3.1.3

10、magnetically induced displacement forceforce pro-duced when a magnetic object is exposed to the spatial gradientof a static magnetic field. This force will tend to cause theobject to translate in the spatial gradient of the static magneticfield.3.1.4 magnetically induced torquetorque produced whena

11、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.3.1.5 magnetic induction or magnetic flux density (B inT)that magnetic vector quantity which at any point in amagnetic f

12、ield 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 pra

13、ctice 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 Aug. 1, 2005. Published August 2005.2For referenced ASTM standards, visit the ASTM website, www.a

14、stm.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 10036.4Available from

15、 International Electrotechnical Commission (IEC), 3 rue deVaremb, Case postale 131, CH-1211, Geneva 20, Switzerland.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.field. B0is the static field in an MR system. Plain type indicatesa s

16、calar (for example, B) and bold type indicates a vector (forexample, B).3.1.6 magnetic resonance (MR)resonant absorption ofelectromagnetic energy by an ensemble of atomic particlesituated in a magnetic field.3.1.7 magnetic resonance (MR) environmentvolumewithin the 0.50 mT (5 gauss (G) line of an MR

17、 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.3.1.8 magnetic resonance system (MR system)ensembleof MR equipment,

18、accessories, including means for display,control, energy supplies, and the MR environment.IEC 60601-2-333.1.9 MR Conditionalan item that has been demonstratedto pose no known hazards in a specified MR environment withspecified conditions of use. Field conditions that define thespecified MR environme

19、nt include field strength, spatial gra-dient, dB/dt (time rate of change of the magnetic field), radiofrequency (RF) fields, and specific absorption rate (SAR).Additional conditions, including specific configurations of theitem, may be required.3.1.10 MR Safean item that poses no known hazards in al

20、lMR 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.3.1.11 MR Unsafean item that is known to pose hazardsin all MR environments.NOTE 2MR U

21、nsafe items include magnetic items such as a pair offerromagnetic scissors.3.1.12 medical deviceany instrument, apparatus, imple-ment, machine, appliance, implant, in vitro reagent or calibra-tor, software, material, or other similar or related article,intended by the manufacturer to be used, alone

22、or in combi-nation, 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

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

24、intended actionin or on the human body by pharmacological, immunological,or metabolic means, but which may be assisted in its functionby such means. ISO 134853.1.13 radio frequency (RF) magnetic fieldthe magneticfield in MRI that is used to flip the magnetic moments. Thefrequency of the RF field is

25、gB0where g is the gyromagneticconstant, 42.56 MHz/T for protons, and B0is the staticmagnetic field in Tesla.3.1.14 safetyfreedom from unacceptable risk in the MRenvironment.3.1.15 specific absorption rate (SAR)the mass normalizedrate at which RF energy is deposited in biological tissue. SARis typica

26、lly indicated in W/kg.3.1.16 tesla, (T)the SI unit of magnetic induction equal to104gauss (G).4. Significance and Use4.1 Medical devices and other items have caused seriousinjuries and death for patients and other individuals in the MRenvironment.4.2 This practice provides a uniform system for marki

27、ng toindicate the MR conditions that have been determined to beacceptable for a medical device or other item. It providessimple visual icons and terms which are intended to reduceinjuries and other mishaps that occur when items that posehazards in the MR environment are brought into the MRenvironmen

28、t.5. Methods of Marking5.1 The marking method should not compromise perfor-mance or function of the marked item and should providelegibility over the anticipated service life of the item.6. Required Information6.1 Perform testing sufficient to characterize the behavior ofthe item in the MR environme

29、nt. In particular, testing for itemsthat may be placed in the MR environment should addressmagnetically induced displacement force (Test MethodF 2052), magnetically induced torque (Test Method F 2213),and RF heating (Test Method F 2182).NOTE 3Other possible safety issues include but are not limited

30、to,thermal injury, induced currents/voltages, electromagnetic compatibility,neurostimulation, acoustic noise, interaction among devices, and the safefunctioning of the item and the safe operation of the MR system.6.2 Any parameter that affects the safety of the item shouldbe listed. Any condition th

31、at is known to produce an unsafecondition must be described.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 markingshould be included in the

32、package labeling (including theinstructions for use and package inserts) and on the patientinformation card. For nonimplanted items intended to be usedin the MR environment, the MR marking should be positionedin a prominent location on the item as well as in the itemlabeling. Some items (for example

33、, small or very thin items) donot provide any surfaces which can be marked practically. Foritems for which direct marking is not practical, the MRmarking should be included in the labeling.7.2 Minimum InformationAs a result of the testing de-scribed in Section 6, mark the item as MR Safe, MR Condi-t

34、ional, or MR Unsafe using the icons as shown in Tables 1 and2.F25030527.2.1 The MR Safe icon consists of the letters “MR”surrounded by a green square (Table 1). Two options are given.When color reproduction is not practical, the icon may beprinted in black and white (Table 2). The use of the colored

35、icon is strongly encouraged for the added visibility andinformation provided by the presence of the color. For bothcolor and black and white options in Tables 1 and 2, the optionthat is most visible for the individual application should bechosen.7.2.2 The MR Conditional icon consists of the letters

36、“MR”within a yellow equilateral triangle with a thick black bandaround the perimeter (Table 1). The triangle is oriented with itshorizontal side below the letters “MR.” When color reproduc-tion is not practical, the icon may be printed in black and white(Table 2). The use of the colored icon is stro

37、ngly encouragedfor the added visibility and information provided by thepresence of the color.7.2.2.1 For MR Conditional items, the item labeling (in-structions for use, package inserts, operator manual, patientinformation card, as appropriate) will include the informationrequired in 3.1.9 and Sectio

38、n 6.7.2.3 The MR Unsafe marking consists of the letters “MR”surrounded by a red circle with a diagonal red bar across theletters extending from the upper left quadrant to the lower rightquadrant of the circle and oriented at 45 from the horizontal(Table 1). When color reproduction is not practical,

39、the iconmay be printed in black and white (Table 2). The use of thecolored icon is strongly encouraged for the added visibility andinformation provided by the presence of the color.7.3 The icons shall comply with the layout requirementsgiven below (see ISO 3864-1 7.2, 7.3, and 7.5). The colors aregi

40、ven in Table 3. Note that the colors represented in anelectronic or paper copy of this document may not match thecolors as defined in Table 3.7.3.1 Color Option 1:7.3.1.1 The colors of the MR Safe icon shall be as followsfor option 1:(1) Background color: green(2) Letters MR: white(3) Border: white(

41、4) The safety color green shall cover at least 50 % of thearea of the icon.(5) The letters MR shall be capitalized, in Arial font andoriented in the center of the square. The letters shall be sized aslarge as possible to be contained within the green square, butnot touching an edge of the green squa

42、re.7.3.2 Color Option 2:7.3.2.1 The colors of the MR Safe icon shall be as followsfor option 2:(1) Background color: white(2) Letters MR: greenTABLE 1 Requirements for Colored MR IconsIcon Geometric Shape and Appearance MeaningA squareMR SafeorAn equilateral triangle with radiused outer cornersMR Co

43、nditionalA circle with a diagonal barMR UnsafeTABLE 2 Requirements for Black and White MR IconsIcon Geometric Shape and Appearance MeaningA squareMR SafeorAn equilateral triangle with radiused outer cornersMR ConditionalA circle with a diagonal barMR UnsafeFIG. 1 Color Option 1FIG. 2 Color Option 2F

44、2503053(3) Border: green. The width of the border shall be 0.1times the length of a side of the square.(4) The letters MR shall be capitalized, in Arial font andoriented in the center of the square. The letters shall be sized aslarge as possible to be contained within the green border, butnot touchi

45、ng an edge of the green border.7.3.3 Black and White Option 1:7.3.3.1 For option 1 of the black and white version of theMR Safe icon, the colors shall be as follows:(1) Background color: black(2) Letters MR: white(3) The black portion of the square shall cover at least 50 %of the total area of the i

46、con.(4) The letters MR shall be capitalized, in Arial font andoriented in the center of the square. The letters shall be sized aslarge as possible to be contained within the black square, butnot touching an edge of the black square.7.3.4 Black and White Option 2:7.3.4.1 For option 2 of the black and

47、 white version of theMR Safe icon, the colors shall be as follows:(1) Background color: white(2) Letters MR: black(3) Border: black. The width of the border shall be 0.1times the length of a side of the square.(4) The letters MR shall be capitalized, in Arial font andoriented in the center of the sq

48、uare. The letters shall be sized aslarge as possible to be contained within the black border, butnot touching an edge of the black border.7.3.5 MR Conditional Icon:7.3.5.1 The colors of the MR Conditional icon shall be asfollows:(1) Background color: yellow(2) Triangular band: black(3) Letters MR: b

49、lack(4) Border: yellow or white(5) The safety color yellow shall cover at least 50 % of thetotal area of the icon.(6) The letters MR shall be capitalized, in Arial font andsized as large as possible to be contained within the blacktriangular band, but not touching the black triangular band.7.3.5.2 For the black and white version of the MR Condi-tional icon, the colors of the icon shall be as follows:(1) Background color: white(2) Triangular band: black(3) Letters MR: black(4) The area within the black band shall cover at least 50 %of th