Object ID: 00000018WIA30950870GYZ
Topic ID: id_40024286 Version: 1.5
Date: Jul 26, 2022 12:07:00 PM

MR compatibility test guidelines

This section document describes a set of specifications and standards that can be used to evaluate the Magnetic Resonance (MR) compatibility of hand-held, non-electronic equipment used in conjunction with the MR system.

Review the following information related to spatial magnetic field data:

A device is labeled as MR Conditional if it has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Field conditions that define the MR environment include static magnetic field strength, static spatial gradient, time rate of change of the magnetic field (dB/dt), RF fields, specific absorption rate (SAR), and coil to be used. Additional conditions, including specific configurations of the item (e.g., the routing of leads used for a neurostimulation system), may be required.

Warning

The attractive force of the magnetic field of the MR system can cause ferrous objects to become projectiles, which can cause serious injury. Post the Security Zone warning sign on the entrance to the magnet room and keep all hazardous objects out of the magnet room.

Warning

GE shall not be responsible for assessing the proper function of any device. The user of the device must consult the device manufacturer to ensure the device is MR Safe or MR Conditional. Then the user must ensure the MR Conditions are met. Finally, the user must determine what is appropriate.

DANGER

Devices compatible at one field strength, such as 1.5T, may not be compatible at another field strength, such as 3.0T . Prior to patient scanning, confirm with the device manufacturer that the device is compatible at your field strength.

MR compatibility standards

The American Society for Testing and Materials, International (ASTM) has developed the following MR compatibility standards (and are developing more):

F1542 Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
F2213 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

These may be ordered online at http://www.astm.org.