Document Center is acquired by Nimonik

Scope

1.1 This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that torque to the equivalent torque applied by the gravitational force to the implant.

1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced force due to spatial gradients in the static magnetic field, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.

1.3 The torque considered here is the magneto-static torque due to the interaction of the MRI static magnetic field with the magnetization in the implant. The dynamic torque due to interaction of the static field with eddy currents induced in a rotating device is not addressed in this test method. Currents in lead wires may induce a torque as well.

1.4 The sensitivity of the torque measurement apparatus must be greater than 1/10 the "gravity torque," the product of the device's maximum linear dimension and its weight.

1.5 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.

Keywords

force, magnetic; implant; metals (for surgical implants); MRI (magnetic resonance imaging); MR safety; torque, magnetic; ICS Number Code 17.220.20 (Measurement of electrical and magnetic quantities)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

17.220.20 (Measurement of electrical and magnetic quantities Including measuring instruments, instrument transformers Electric energy meters in buildings, see 91.140.50)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.