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ASTM F 2182 : 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

01-09-2020

Published date

01-06-2002

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Superseded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

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.

ASTM F 2119 : 2007 : R2013 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)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 1831 : 2017 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
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
ASTM F 3160 : 2016 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants

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