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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 8-571
Standard
ASTM  F2052-21
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Scope/Abstract
1.1 This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) 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, radiofrequency (RF) heating, induced heating, acoustic noise, interaction among devices, and the functionality of the device and the magnetic resonance (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 horizontal bore MR system with a static magnetic field oriented horizontally and parallel to the MR system bore.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, Issued May 2021

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Terry O. Woods
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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