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Scope

1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients on medical devices and the comparison of that force to the weight of the medical device.

1.2 This test method does not address other possible safety issues which include but are not limited to issues of magnetically induced torque, RF heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the MR system.

1.3 This test method is intended for devices that can be suspended from a string. Devices which cannot be suspended from a string are not covered by this test method. The weight of the string from which the device is suspended during the test must be less than 1 % of the weight of the tested device.

1.4 This test method shall be carried out in a system in which the direction of the magnetically induced deflection force is horizontal.

1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.

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 requirements prior to use.

Keywords

medical device; metals (for surgical implants and medical devices); MRI (magnetic resonance imaging); MR safety; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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