New Guide for Characterization of Magnetically-Induced Force on Medical Devices and other Items intended for the Bo Far Field Magnetic Resonance Environment
1. Scope
1.1 This test method covers the characterization of the magnetically-induced force produced by static magnetic field and its spatial field gradient on a medical device or other item intended for MR Conditional use in the Bo far field (i.e., the space around MR equipment where the static magnetic field strength (B0), is = 200 mT) of the magnetic resonance environment.
1.2 This test method does not address the functionality of the item in the magnetic resonance (MR) environment.
1.3 This test method shall be carried out using a cylindrical whole-body MR equipment with a static magnetic field oriented horizontally and parallel to the MR equipment bore.
1.4 The results can be applicable to whole-body clinical MR equipment (e.g. 1.2 T, 1.5 T, 3.0 T, 7.0 T MR equipment).
Keywords
MRI Safety
Rationale
The standard will be used by manufacturers of medical devices and other items to develop MRI safety labeling for non- implanted devices and other items intended to remain outside an MRI system. It may also be used by test houses or clinical practitioners.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 06-13-2022
Technical Contact: Brian Choules
Item: 001
Ballot: F04.15 (23-02)
Status: Will Reballot Item
Item: 008
Ballot: F04 (24-04)
Status: Will Reballot Item