Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
|Publication Date:||1 October 2021|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of that force to the weight of the medical device.
This test method does not address other possible safety issues which include, but are not limited to: issues of magnetically induced torque, radiofrequency (RF) heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the magnetic resonance (MR) system.
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.
This test method shall be carried out in a horizontal bore MR system with a static magnetic field oriented horizontally and parallel to the MR system bore.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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.