Norm

ASTM F2213-06(2011)

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

54,27

Over deze norm

Status Definitief
Aantal pagina's 8
Commissie F04.15
Gepubliceerd op 01-10-2011
Taal Engels

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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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.

Details

ICS-code 17.220.20
Nederlandse titel Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Engelse titel Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

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