ASTM F2052-00
Historical Standard: ASTM F2052-00 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment
SUPERSEDED (see Active link, below)
ASTM F2052
1. Scope
1.1 This standard test method covers the measurement of the magnetically induced displacement force produced by the spatial gradients of a magnetic field on passive implants (implants that function without the supply of electrical power) and the comparison of that force to the weight of the implant.
1.2 This method does not address the issues of magnetically induced torque or RF heating.
1.3 This method is intended for devices that can be suspended from a thin string. Devices which cannot be suspended from a thin string are not covered by this test method.
1.4 The weight of the thin string from which the device is suspended during the test must be less than 1% of the weight of the tested device.
1.5 This method is applicable only to magnet systems in which the direction of the magnetic field (and the direction of the magnetically induced deflection force) is horizontal.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Other Standards
ISO 13485:2003(E) Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes, definition 3.7ASTM Standards
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2213 Test Method for 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
Keywords
medical device; metals (for surgical implants and medical devices); MRI (magnetic resonance imaging); MR safety;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F2052-00
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