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ASTM F2052-02

(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

SCOPE
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients 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, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the 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 system in which the direction of the magnetically induced deflection force is horizontal.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.
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 and health practices and determine the applicability of regulatory requirements prior to use.

General Information

Status
Historical
Publication Date
09-Nov-2002
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F2052-00 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment
Effective Date
10-Nov-2002
Replaced By
ASTM F2052-06 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Effective Date
01-Mar-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
10-Nov-2002
Referred By
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Effective Date
10-Nov-2002
Referred By
ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
Effective Date
10-Nov-2002
Referred By
ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
Effective Date
10-Nov-2002
Referred By
ASTM F2503-23 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Effective Date
10-Nov-2002
Referred By
ASTM F1831-17 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
Effective Date
10-Nov-2002

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ASTM F2052-02 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentASTM F2052-02 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
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ASTM F2052-02 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
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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:F2052–02
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 F 2052; 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 2119 Test Method for Evaluation of MR Image Artifacts
3
from Passive Implants
1.1 This test method covers the measurement of the mag-
F 2182 Test Method for Measurement of Radio Frequency
netically induced displacement force produced by static mag-
Induced Heating Near Passive Implants During Magnetic
netic field gradients on medical devices and the comparison of
3
Resonance Imaging
that force to the weight of the medical device.
1.2 This test method does not address other possible safety
3. Terminology
issues which include but are not limited to issues of magneti-
3.1 Definitions:
cally induced torque, RF heating, induced heating, acoustic
3.1.1 diamagnetic material—a material whose relative per-
noise, interaction among devices, and the functionality of the
meability is less than unity.
device and the MR system.
3.1.2 ferromagnetic material—a material whose magnetic
1.3 This test method is intended for devices that can be
moments are ordered and parallel producing magnetization in
suspended from a string. Devices which cannot be suspended
one direction.
from a string are not covered by this test method. The weight
3.1.3 magnetic field strength (H in A/m)—strength of the
ofthestringfromwhichthedeviceissuspendedduringthetest
applied magnetic field.
must be less than 1 % of the weight of the tested device.
3.1.4 magnetic induction or magnetic flux density (B in
1.4 This test method shall be carried out in a system in
T)—that magnetic vector quantity which at any point in a
which the direction of the magnetically induced deflection
magnetic field is measured either by the mechanical force
force is horizontal.
experiencedbyanelementofelectriccurrentatthepoint,orby
1.5 The values stated in SI units are to be regarded as
the electromotive force induced in an elementary loop during
standard. Values in parentheses are for information only.
any change in flux linkages with the loop at the point. The
1.6 This standard does not purport to address all of the
magnetic induction is frequently referred to as the magnetic
safety concerns, if any, associated with its use. It is the
field. B isthestaticfieldinanMRsystem.Plaintypeindicates
o
responsibility of the user of this standard to establish appro-
a scalar (for example, B) and bold type indicates a vector (for
priate safety and health practices and determine the applica-
example,B).
bility of regulatory requirements prior to use.
3.1.5 magnetic resonance diagnostic device—a device in-
2. Referenced Documents tended for general diagnostic use to present images which
reflectthespatialdistributionormagneticresonancespectra,or
2.1 ASTM Standards:
both, which reflect frequency and distribution of nuclei exhib-
A 340 Terminology of Symbols and Definitions Relating to
2
iting nuclear magnetic resonance. Other physical parameters
Magnetic Testing
derived from the images or spectra, or both, may also be
F 1542 Specification for the Requirements and Disclosure
3
produced.
of Self-Closing Aneurysm Clips
3.1.6 magnetic resonance (MR) environment—area within
the 5 gauss (G) line of an MR system.
1 3.1.7 magnetic resonance equipment (MR equipment)—
This test method is under the jurisdiction ofASTM Committee F04 on Medical
medical electrical equipment which is intended for in-vivo
& Surgical Materials & Devices and is the direct responsibility of Subcommittee
F04.15 on Materials Test Methods.
magnetic resonance examination of a patient. The MR equip-
Current edition approved Nov. 10, 2002. Published December 2002. Originally
ment comprises all parts in hardware and software from the
approved in 2000. Last previous edition approved in 2000 as F 2052 – 00.
2 supply mains to the display monitor. The MR equipment is a
Annual Book of ASTM Standards, Vol 03.04.
3
Annual Book of ASTM Standards, Vol 13.01. Programmable Electrical Medical System (PEMS).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2052–02
3.1.8 magnetic resonance system (MR system)—ensemble 6. Apparatus
of MR equipment, accessories, including means for display,
6.1 The test fixture consists of a sturdy nonmagnetic struc-
control, energy supplies, and the MR environment.
ture capable of holding the test device in the proper pos
...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
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A1.1 Significance and Use
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off