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ASTM F 2182 : 2019

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Available format(s)

Hardcopy , PDF

Superseded date

27-01-2020

Language(s)

English

Published date

01-10-2019

1.1This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not specify levels of heating considered to be safe to the patient and relies on users to define their own acceptance criteria.

1.2This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced-displacement, magnetically-induced torque, image artifact, acoustic noise, tissue heating, interaction among devices, and the functionality of the device and the MR system.

1.3The amount of RF-induced temperature rise (∆T) for a given incident electric field will depend on the RF frequency, which is dependent on the static magnetic field strength of the MR system. While the focus in this test method is on 1.5 tesla (T) or 3 T MR systems, the ∆T for an implant in MR systems of other static magnetic field strengths or magnet designs can be evaluated by suitable modification of the method described herein.

1.4This test method assumes that testing is done on devices that will be entirely inside the body. Testing for devices with other implantation conditions (for example, external fixation devices, percutaneous needles, catheters or tethered devices such as ablation probes) is beyond the scope of this standard; for such devices, modifications of this test method may be necessary.

Note 1:RF-heating induced by any electrically conductive implanted device may be impacted by the presence of other metallic or otherwise electrically conductive devices present nearby.

1.5This test method is written for several possible RF exposure systems, including Volume RF transmit coils. The exposure system needs to be properly characterized, within the stated uncertainties, in term of local background RF exposure for the implants which are tested.

1.6The values stated in SI units are to be regarded as standard.

1.7A device with deployed dimensions of less than 2 cm in all directions does not need to be tested with respect to RF-induced heating, as it is expected to generate ∆T of less than 2°C over 1 hour of exposure at 1.5 T and 3 T frequencies (1, 22 and ANSI/AAMI/ISO 14708-3:2017). This condition is not valid when multiple replicas of the device (for example, multiple anchors) are implanted within 3 cm of the device.

Note 2:The above values were derived from existing data and literature. The 3 cm distance is recommended to avoid any RF coupling with other neighboring devices.

1.8This 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.

1.9This 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.

Committee
F 04
DocumentType
Test Method
Pages
11
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 1831 : 2017 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
ASTM F 3160 : 2016 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
ASTM F 2119 : 2007 : R2013 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)
ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F 2052 : 2015 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F 2213 : 2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F 2503 : 2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

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