ASTM F2213-02 - 10.11.2002
 
1. 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 passive implants (implants that function without the supply of electrical power) 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 the issue of magnetically induced force due to spatial gradients in the static magnetic field.

1.3 The torque considered here is the 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.

1.4 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.

 
2. Referenced Documents

F2119-07

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

F2182-19e2

Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (Includes all amendments and changes 4/7/2020).

F2503-23e1

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment (Includes all amendments and changes 10/24/2023).

F2052-21

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ISO 13485:2003(E)

Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes, definition 3.7