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ASTM F2182-02a

(Test Method)

Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

SIGNIFICANCE AND USE
This test method describes a test procedure for evaluating the RF-induced temperature rise in MRI in the vicinity of an implanted medical device. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. The conditions and results of the testing should be included in the device labeling so that the attending physician can make the decision of whether to allow the patient with the implant to undergo an MRI procedure.
SCOPE
1.1 This test method covers measurement of Radio Frequency (RF) induced heating near a passive medical implant and its surroundings during Magnetic Resonance Imaging (MRI).
1.2 This test method is one of those required to determine if the presence of a passive implant may cause injury to the person with the implant during an MRI procedure. Other safety issues that should be addressed include magnetically induced displacement force and torque.
1.3 The amount of RF-induced temperature rise for a given specific absorption rate (SAR) will depend on the RF frequency, which is proportional to the static magnetic field strength. Because of possible additional heating, particularly when device dimensions exceed a quarter wavelength, conclusions from measurements made at one frequency may not apply to other frequencies.
1.4 This test method assumes that testing is done on devices that will be entirely inside the body.
1.5 This test method applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of the IEC Standard 60601-2-33 with a whole body RF transmit coil as defined in section 2.2.100. The RF coil is assumed to have quadrature excitation.
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 limitations 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 F2182-02 - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
Effective Date
10-Nov-2002
Replaced By
ASTM F2182-09 - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
Effective Date
15-Nov-2009
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
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
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 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 F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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

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ASTM F2182-02a - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance ImagingASTM F2182-02a - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
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ASTM F2182-02a - Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
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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:F2182–02a
Standard Test Method for
Measurement of Radio Frequency Induced Heating Near
1
Passive Implants During Magnetic Resonance Imaging
This standard is issued under the fixed designation F2182; 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 2. Referenced Documents
2
1.1 This test method covers measurement of Radio Fre- 2.1 ASTM Standards:
quency (RF) induced heating near a passive medical implant A340 Terminology of Symbols and Definitions Relating to
3
and its surroundings during Magnetic Resonance Imaging Magnetic Testing
(MRI). F2052 Test Method for Measurement of Magnetically In-
1.2 This test method is one of those required to determine if duced Displacement Force on Medical Devices in the
3
the presence of a passive implant may cause injury to the Magnetic Resonance Environment
personwiththeimplantduringanMRIprocedure.Othersafety F2119 Test Method for Evaluation of MR Image Artifacts
issues that should be addressed include magnetically induced from Passive Implants
4
displacement force and torque. 2.2 IEC Standard:
1.3 The amount of RF-induced temperature rise for a given 60601-2-33, Ed. 2.0 Medical Electrical Equipment—Part 2:
specific absorption rate (SAR) will depend on the RF fre- Particular Requirements for the Safety of Magnetic Reso-
quency, which is proportional to the static magnetic field nance Equipment for Medical Diagnosis, 2002
strength. Because of possible additional heating, particularly
3. Terminology
when device dimensions exceed a quarter wavelength, conclu-
sions from measurements made at one frequency may not 3.1 Definitions—For the purposes of this test method, the
definitions in 3.1.1-3.1.10 shall apply.
apply to other frequencies. While the focus in this test method
is on 1.5 T cylindrical bore imagers, the RF-induced tempera- 3.1.1 isocenter—geometric center of the gradient coil sys-
tem, which generally is the geometric center of a scanner with
ture rise in the open MRI systems can be evaluated by suitable
a cylindrical bore.
modification of the methods described here.
1.4 This test method assumes that testing is done on devices 3.1.2 magnetic resonance imaging (MRI)—diagnostic im-
aging technique that uses static and time varying magnetic
that will be entirely inside the body.
1.5 This test method applies to whole body magnetic fields to provide images of tissue by the magnetic resonance of
nuclei.
resonance equipment, as defined in section 2.2.103 of the IEC
Standard 60601-2-33, Ed. 2.0, with a whole body RF transmit 3.1.3 magnetic resonance (MR) environment—area within
the 5 G line of an MR system.
coil as defined in section 2.2.100. The RF coil is assumed to
have quadrature excitation. 3.1.4 magnetic resonance system (MR System)—ensemble
of MR equipment, accessories including means for display,
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the control, energy supplies, and the MR environment.
3.1.5 medical implant—a structure or device that is placed
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- within the body of the patient for medical diagnostic or
therapeutic purposes.
bility of regulatory limitations prior to use.
3.1.6 MR safe—the device, when used in the MR environ-
ment, has been demonstrated to present no additional risk to
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
andSurgicalMaterialsandDevices andisthedirectresponsibilityofSubcommittee
2
F04.15 on Material Test Methods. Annual Book of ASTM Standards, Vol 03.04.
3
Current edition approved Nov. 10, 2002. Published December 2002. Originally Annual Book of ASTM Standards, Vol 13.01.
4
approved in 2002. Last previous edition approved in 2002 as F2182 – 02. DOI: Available from the International Electrotechnical Commission (IEC), 3 rue de
10.1520/F2182-02A. 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 ----------------------
F2182–02a
the patient or other individuals, but may affect the quality of 6.2 Temperature Sensor—Asuitable temperature measuring
the diagnostic information. The MR conditions in which the device, usually a fiber optic probe, is used to measure tempera-
device was tested should be specified in conjunction with the ture versus time of RF exposure in the vicinity of the implant.
termsMRsafeandMRcompatiblesinceadevicewhichissafe The
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
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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ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

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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.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 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. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
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