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ASTM F2213-04

(Test Method)

Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment

Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment

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.
1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, 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 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 a torque as well.
1.4 The sensitivity of the torque measurement apparatus must be greater than 1/10 the "gravity torque," the product of the device's maximum linear dimension and its weight.
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Dec-2003
ICS
17.220.20 - Measurement of electrical and magnetic quantities
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F2213-02 - Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment
Effective Date
01-Jan-2004
Replaced By
ASTM F2213-06 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Effective Date
01-May-2006
Referred By
ASTM F2182-19e2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Effective Date
01-Jan-2004
Referred By
ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Effective Date
01-Jan-2004
Referred By
ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
Effective Date
01-Jan-2004
Referred By
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Effective Date
01-Jan-2004
Referred By
ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
Effective Date
01-Jan-2004
Referred By
ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
Effective Date
01-Jan-2004

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ASTM F2213-04 - Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance EnvironmentASTM F2213-04 - Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment
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ASTM F2213-04 - Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2213 – 04
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 F 2213; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 2052 Test Method for Measurement of Magnetically In-
duced Displacement Force on Medical Devices in the
1.1 This test method covers the measurement of the mag-
Magnetic Resonance Environment
netically induced torque produced by the static magnetic field
F 2119 Test Method for Evaluation of MR Image Artifacts
inthemagneticresonanceenvironmentonmedicaldevicesand
from Passive Implants
the comparison of that torque to the equivalent torque applied
F 2182 Test Method for Measurement of Radio Frequency
by the gravitational force to the implant.
Induced Heating Near Passive Implants During Magnetic
1.2 This test method does not address other possible safety
Resonance Imaging
issues which include but are not limited to issues of magneti-
2.2 IEC Standard:
cally induced force due to spatial gradients in the static
60601-2-33 Ed. 2.0 Medical Electrical Equipment—Part 2:
magnetic field, RF heating, induced heating, acoustic noise,
Particular Requirements for the Safety of Magnetic Reso-
interaction among devices, and the functionality of the device
3
nance Equipment for Medical Diagnosis, 2002
and the MR system.
1.3 The torque considered here is the magneto-static torque
3. Terminology
due to the interaction of the MRI static magnetic field with the
3.1 Definitions—For the purposes of this test method, the
magnetization in the implant. The dynamic torque due to
definitions in 3.1.1-3.1.18 shall apply:
interaction of the static field with eddy currents induced in a
3.1.1 diamagnetic material—a material whose relative per-
rotating device is not addressed in this test method. Currents in
meability is less than unity.
lead wires may induce a torque as well.
3.1.2 ferromagnetic material—a material whose magnetic
1.4 The sensitivity of the torque measurement apparatus
1 moments are ordered and parallel producing magnetization in
mustbegreaterthan ⁄10the“gravitytorque,”theproductofthe
one direction.
device’s maximum linear dimension and its weight.
3.1.3 magnetic induction or magnetic flux density (B in
1.5 This standard does not purport to address all of the
T)—that magnetic vector quantity which at any point in a
safety concerns, if any, associated with its use. It is the
magnetic field is measured either by the mechanical force
responsibility of the user of this standard to establish appro-
experiencedbyanelementofelectriccurrentatthepoint,orby
priate safety and health practices and determine the applica-
the electromotive force induced in an elementary loop during
bility of regulatory limitations prior to use.
any change in flux linkages with the loop at the point. The
2. Referenced Documents magnetic induction is frequently referred to as the magnetic
2
field. B isthestaticfieldinanMRsystem.Plaintypeindicates
0
2.1 ASTM Standards:
a scalar (for example, B) and bold type indicates a vector (for
A 340 Terminology of Symbols and Definitions Relating to
example,B).
Magnetic Testing
3.1.4 magnetic field strength (H in A/m)—strength of the
F 1542 Specification for the Requirements and Disclosure
applied magnetic field.
of Self-Closing Aneurysm Clips
3.1.5 magnetic resonance (MR)—resonant absorption of
electromagnetic energy by an ensemble of atomic particle
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical situated in a magnetic field.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.6 magnetic resonance diagnostic device—a device in-
F04.15 on Material Test Methods.
tended for general diagnostic use to present images which
Current edition approved Jan. 1, 2004. Published February 2004. Originally
approved in 2002. Last previous edition approved in 2002 as F 2213 – 02.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from the International Electrotechnical Commission (IEC), 3 rue de
the ASTM website. Varembe, Case postale 131, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2213–04
reflectthespatialdistributionormagneticresonancespectra,or measurement of
...

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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.  
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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...
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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.  
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5.4 Provided geometrically identical shields are compared, this test method is also suitable for evaluation and grading of magnetic shielding materials.
SCOPE
1.1 This test method covers the means for determining the performance quality of a magnetic shield when placed in a magnetic field of alternating polarity.  
1.2 This test method provides a means of evaluating and grading magnetic shielding materials to determine their suitability for use in the production of magnetic shields.  
1.3 This test method shall be used in conjunction with and shall conform to the requirements of Practice A34/A34M.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.5 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.  
1.6 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.

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ASTM
ASTM B878-97(2019)(Test Method)
Standard Test Method for Nanosecond Event Detection for Electrical Contacts and Connectors

SIGNIFICANCE AND USE
4.1 The tests in this test method are designed to assess the resistance stability of electrical contacts or connections.  
4.2 The described procedures are for the detection of events that result from short duration, high-resistance fluctuations, or of voltage variations that may result in improper triggering of high speed digital circuits.  
4.3 In those procedures, the test currents are 100 mA (±20 mA) when the test sample has a resistance between 0 and 10 Ω. Since the minimum resistance change required to produce an event (defined in 3.2.1) is specified as 10 Ω (see 1.3), the voltage increase required to produce this event must be at least 1.0 V.  
4.4 The detection of nanosecond-duration events is considered necessary when an application is susceptible to noise. However, these procedures are not capable of determining the actual duration of the event detected.  
4.5 The integrity of nanosecond-duration signals can only be maintained with transmission lines; therefore, contacts in series are connected to a detector channel through coaxial cable. The detector will indicate when the resistance monitored exceeds the minimum event resistance for more than the specified duration.  
4.6 The test condition designation corresponding to a specific minimum event duration of 1, 10, or 50 ns is listed in Table 1. These shall be specified in the referencing document.
SCOPE
1.1 This test method describes equipment and techniques for detecting contact resistance transients yielding resistances greater than a specified value and lasting for at least a specified minimum duration.  
1.2 The minimum durations specified in this standard are 1, 10, and 50 nanoseconds (ns).  
1.3 The minimum sample resistance required for an event detection in this standard is 10 Ω.  
1.4 An ASTM guide for measuring electrical contact transients of various durations is available as Guide B854.  
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 become familiar with all hazards including those identified in the appropriate Material Safety Data Sheet (MSDS) for this product/material as provided by the manufacturer, 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.

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