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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 horizontal bore MR system with a static magnetic filed oriented horizontally and parallel to the MR system bore.
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 establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42203700(Medical imaging processing equipment and supplies)
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ASTM F2052-14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM International, West Conshohocken, PA, 2014, www.astm.orgBack to Top