ASTM F2052-21
(Test Method)Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
SIGNIFICANCE AND USE
5.1 This test method is one of those required to determine if the presence of a medical device may cause injury to individuals during an MR examination or in the MR environment. Other safety issues which should be addressed include, but may not be limited to: magnetically induced torque (see Test Method F2213) and radiofrequency (RF) heating (see Test Method F2182). The terms and icons in Practice F2503 should be used to mark the device for safety in the magnetic resonance environment.
5.2 If the maximum magnetically induced displacement force for the specified magnetic field conditions (see Appendix X3) is less than the force on the device due to gravity (its weight), it is assumed that any risk imposed by the application of the magnetically induced force is no greater than any risk imposed by normal daily activity in the Earth’s gravitational field. This statement does not constitute an acceptance criterion; it is provided as a conservative reference point. It is possible that a greater magnetically induced displacement force can be acceptable and would not harm a patient or other individual in a specific case.
Note 2: For instance, in the case of an implanted device that is or could be subjected to a magnetic displacement force greater than the force due to gravity, the location of the implant, surrounding tissue properties, and means of fixation within the body may be considered. For a non-implanted device with a magnetically induced force greater than the gravitational force, consideration should be given to mitigate the projectile risk which may include fixing or tethering the device or excluding it from the MR environment so that it does not become a projectile.
5.3 The maximum static magnetic field strength and spatial field gradient vary for different MR systems. Appendix X3 provides guidance for calculating the allowable static magnetic field strength and spatial field gradient.
5.4 This test method alone is not sufficient for determining if a d...
SCOPE
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of that force to the weight of the medical device.
1.2 This test method does not address other possible safety issues which include, but are not limited to: issues of magnetically induced torque, radiofrequency (RF) heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the magnetic resonance (MR) system.
1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 1 % of the weight of the tested device.
1.4 This test method shall be carried out in a horizontal bore MR system with a static magnetic field oriented horizontally and parallel to the MR system bore.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Buy Standard
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2052 − 21
Standard Test Method for
Measurement of Magnetically Induced Displacement Force
on Medical Devices in the Magnetic Resonance
1
Environment
This standard is issued under the fixed designation F2052; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This test method covers the measurement of the mag-
netically induced displacement force produced by static mag-
2. Referenced Documents
netic field gradients (spatial field gradient) on medical devices
2
2.1 ASTM Standards:
and the comparison of that force to the weight of the medical
E177Practice for Use of the Terms Precision and Bias in
device.
ASTM Test Methods
1.2 This test method does not address other possible safety
E691Practice for Conducting an Interlaboratory Study to
issues which include, but are not limited to: issues of magneti-
Determine the Precision of a Test Method
cally induced torque, radiofrequency (RF) heating, induced
F136 Specification for Wrought Titanium-6Aluminum-
heating, acoustic noise, interaction among devices, and the
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
functionality of the device and the magnetic resonance (MR)
Implant Applications (UNS R56401)
system.
F138 Specification for Wrought 18Chromium-14Nickel-
2.5MolybdenumStainlessSteelBarandWireforSurgical
1.3 This test method is intended for devices that can be
suspended from a string. Devices which cannot be suspended Implants (UNS S31673)
F1537 Specification for Wrought Cobalt-28Chromium-
from a string are not covered by this test method. The weight
ofthestringfromwhichthedeviceissuspendedduringthetest 6Molybdenum Alloys for Surgical Implants (UNS
R31537, UNS R31538, and UNS R31539)
must be less than 1% of the weight of the tested device.
F2119Test Method for Evaluation of MR Image Artifacts
1.4 Thistestmethodshallbecarriedoutinahorizontalbore
from Passive Implants
MR system with a static magnetic field oriented horizontally
F2182Test Method for Measurement of Radio Frequency
and parallel to the MR system bore.
Induced Heating On or Near Passive Implants During
1.5 The values stated in SI units are to be regarded as
Magnetic Resonance Imaging
standard. No other units of measurement are included in this
F2213Test Method for Measurement of Magnetically In-
standard.
duced Torque on Medical Devices in the Magnetic Reso-
nance Environment
1.6 This standard does not purport to address all of the
F2503Practice for Marking Medical Devices and Other
safety concerns, if any, associated with its use. It is the
Items for Safety in the Magnetic Resonance Environment
responsibility of the user of this standard to establish appro-
3
2.2 Other Standards:
priate safety, health, and environmental practices and deter-
IEC60601-2-33Ed. 3.2 Medical Electronic Equipment—
mine the applicability of regulatory limitations prior to use.
Part2:ParticularRequirementsfortheSafetyofMagnetic
1.7 This international standard was developed in accor-
Resonance Equipment for Medical Diagnosis
dance with internationally recognized principles on standard-
GHTF/SG1/N071:2012 definition 5.1, Definition of the
ization established in the Decision on Principles for the
Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD)
Development of International Standards, Guides and Recom-
Medical Device’
1 2
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Oct. 1, 2021. Published January 2022. Originally the ASTM website.
3
approved in 2000. Last previous edition approved in 2015 as F2052–15. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2052-21. 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 States
1
---------------------- Page: 1 ----------------------
F2052 − 21
3. Terminology (1)Diagnosis, prevention, monitoring, treatment, or alle-
viation of disease;
3.1 Definitions:
(2)Diagnosis, monitoring, treatment, allevia
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2052 − 15 F2052 − 21
Standard Test Method for
Measurement of Magnetically Induced Displacement Force
on Medical Devices in the Magnetic Resonance
1
Environment
This standard is issued under the fixed designation F2052; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field
gradients (spatial field gradient) on medical devices and the comparison of that force to the weight of the medical device.
1.2 This test method does not address other possible safety issues which include, but are not limited toto: issues of magnetically
induced torque, RF radiofrequency (RF) heating, induced heating, acoustic noise, interaction among devices, and the functionality
of the device and the MR magnetic resonance (MR) system.
1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string
are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than
1 % of the weight of the tested device.
1.4 This test method shall be carried out in a horizontal bore MR system with a static magnetic filedfield oriented horizontally and
parallel to the MR system bore.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine the
applicability of regulatory requirementslimitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Sept. 15, 2015Oct. 1, 2021. Published September 2015January 2022. Originally approved in 2000. Last previous edition approved in 20142015
as F2052 – 14.F2052 – 15. DOI: 10.1520/F2052-15.10.1520/F2052-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2052 − 21
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
3
2.2 Other Standards:
IEC 60601–2–33IEC 60601-2-33 Ed. 2.03.2 Medical Electronic Equipment—Part 2: Particular Requirements for the Safety of
Magnetic Resonance Equipment for Medical Diagnosis
ISO 13485:2003(E)GHTF/SG1/N071:2012 Medical Devices—Quality Management Systems—Requirements for Regul
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.