ASTM F2213-17
(Test Method)Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Standard Test Method for Measurement of Magnetically Induced Torque 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 in the magnetic resonance environment. Other safety issues which should be addressed include but may not be limited to magnetically induced force (see Test Method F2052), RF heating (see Test Method F2182), and image artifact (see Test Method F2119). ISO TS 10974 addresses hazards produced by active implantable medical devices in the MR Environment.
5.2 The terms MR Conditional, MR Safe, and MR Unsafe together with the corresponding icons in Practice F2503 shall be used to mark the device for safety in the MR environment.
5.3 The acceptance criterion associated with this test shall be justified. If the maximum magnetically induced torque is less than the product of the longest dimension of the medical device and its weight, then the magnetically induced torque is less than the worst case torque on the device due to gravity. For this condition, it is assumed that any risk imposed by the application of the magnetically induced torque is no greater than any risk imposed by normal daily activity in the Earth's gravitational field. This is conservative. It is possible that greater torques also would not pose a hazard. (For example, device position with respect to adjacent tissue, tissue ingrowth, or other mechanisms may act to prevent device movement or forces produced by a magnetically induced torque that are greater than the torque due to gravity from causing harm to adjacent tissue.)
5.4 This test method alone is not sufficient for determining if an implant is safe in the MR environment.
5.5 The magnetically induced torque considered in this standard is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce...
SCOPE
1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque a user-specified acceptance criterion.
1.2 This test method does not address other possible safety issues which may include, but are not limited to, magnetically induced deflection force, tissue heating, device malfunction, imaging artifacts, acoustic noise, interaction among devices, and the functionality of the device and the MR system.
1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization of the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Torque induced by currents in lead wires is not addressed by this standard.
1.4 The methods in this standard are applicable for MR systems with a horizontal magnetic field. Not all of the methods described in this standard are applicable for use in an MR system with a vertical magnetic field. The Suspension Method and the Low Friction Surface Method require gravity to be orthogonal to the magnetically induced torsion and may not be performed using a vertical magnetic field. The Torsional Spring and Pulley Methods can be adapted to work in a vertical magnetic field, however the example apparatus are not appropriate for use in a vertical magnetic field. The Calculation Based on Measured Displacement Force Method is independent of the MR system and thus could be used for an MR system with a vertical magnetic field.
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 u...
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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: F2213 − 17
Standard Test Method for
Measurement of Magnetically Induced Torque on Medical
1
Devices in the Magnetic Resonance Environment
This standard is issued under the fixed designation F2213; 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 1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This test method covers the measurement of the mag-
responsibility of the user of this standard to establish appro-
netically induced torque produced by the static magnetic field
priate safety, health, and environmental practices and deter-
inthemagneticresonanceenvironmentonmedicaldevicesand
mine the applicability of regulatory limitations prior to use.
the comparison of that torque a user-specified acceptance
1.7 This international standard was developed in accor-
criterion.
dance with internationally recognized principles on standard-
1.2 This test method does not address other possible safety
ization established in the Decision on Principles for the
issues which may include, but are not limited to, magnetically
Development of International Standards, Guides and Recom-
induced deflection force, tissue heating, device malfunction,
mendations issued by the World Trade Organization Technical
imaging artifacts, acoustic noise, interaction among devices,
Barriers to Trade (TBT) Committee.
and the functionality of the device and the MR system.
1.3 The torque considered here is the magneto-static torque
2. Referenced Documents
due to the interaction of the MRI static magnetic field with the
2
2.1 ASTM Standards:
magnetization of the implant. The dynamic torque due to
F2052Test Method for Measurement of Magnetically In-
interaction of the static field with eddy currents induced in a
duced Displacement Force on Medical Devices in the
rotating device is not addressed in this test method. Torque
Magnetic Resonance Environment
induced by currents in lead wires is not addressed by this
F2119Test Method for Evaluation of MR Image Artifacts
standard.
from Passive Implants
1.4 The methods in this standard are applicable for MR
F2182Test Method for Measurement of Radio Frequency
systems with a horizontal magnetic field. Not all of the
Induced Heating On or Near Passive Implants During
methods described in this standard are applicable for use in an
Magnetic Resonance Imaging
MR system with a vertical magnetic field. The Suspension
F2503Practice for Marking Medical Devices and Other
Method and the Low Friction Surface Method require gravity
Items for Safety in the Magnetic Resonance Environment
to be orthogonal to the magnetically induced torsion and may
3
2.2 Other Standards:
notbeperformedusingaverticalmagneticfield.TheTorsional
IEC 60601-2-33Medical electrical equipment - Part 2-33:
SpringandPulleyMethodscanbeadaptedtoworkinavertical
Particular requirements for the basic safety and essential
magnetic field, however the example apparatus are not appro-
performance of magnetic resonance equipment for medi-
priate for use in a vertical magnetic field. The Calculation
cal diagnosis
Based on Measured Displacement Force Method is indepen-
ISO 13485Medical devices -- Quality management systems
dent of the MR system and thus could be used for an MR
4
-- Requirements for regulatory purposes
system with a vertical magnetic field.
ISO TS 10974Assessment of the safety of magnetic reso-
1.5 The values stated in SI units are to be regarded as
nance imaging for patients with an active implantable
standard. No other units of measurement are included in this
medical device
standard.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.15 on Material Test Methods. the ASTM website.
3
Current edition approved Sept. 1, 2017. Published October 2017. Originally Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
approved in 2002. Last previous edition approved in 2011 as F2213–06(2011). 4th Floor, New York, NY 10036, http://www.ansi.org.
4
DOI: 10.1520/F2213-17. Specifically, definition 3.11.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken,
...
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: F2213 − 06 (Reapproved 2011) F2213 − 17
Standard Test Method for
Measurement of Magnetically Induced Torque on Medical
1
Devices in the Magnetic Resonance Environment
This standard is issued under the fixed designation F2213; 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 torque produced by the static magnetic field in the
magnetic resonance environment on medical devices and the comparison of that torque to the equivalent torque applied by the
gravitational force to the implant.a user-specified acceptance criterion.
1.2 This test method does not address other possible safety issues which include may include, but are not limited to issues of
magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, to, magnetically
induced deflection force, tissue heating, device malfunction, imaging artifacts, acoustic noise, interaction among devices, and the
functionality of the device and the MR system.
1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the
magnetization inof the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating
device is not addressed in this test method. Currents Torque induced by currents in lead wires may induce a torque as well.is not
addressed by this standard.
1.4 The sensitivity of the torque measurement apparatus must be greater thanmethods in this standard are applicable for MR
systems with a horizontal magnetic field. Not all of the methods described in this standard are applicable for use in an MR system
with a vertical magnetic field. The Suspension Method and the Low Friction Surface Method require gravity to be orthogonal to
the magnetically induced torsion and may not be performed using a vertical magnetic field. The Torsional Spring and Pulley
1
Methods can be adapted to work in a vertical magnetic field, however the example apparatus are not appropriate for ⁄10 the “gravity
torque,” the product of the device’s maximum linear dimension and its weight.use in a vertical magnetic field. The Calculation
Based on Measured Displacement Force Method is independent of the MR system and thus could be used for an MR system with
a vertical magnetic field.
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 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
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
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 Oct. 1, 2011Sept. 1, 2017. Published October 2011October 2017. Originally approved in 2002. Last previous edition approved in 20062011 as
F2213 – 06.F2213 – 06 (2011). DOI: 10.1520/F2213-06R11.10.1520/F2213-17.
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
...
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