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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 031 Date of Entry 08/06/2013 
FR Recognition Number 8-153
Standard
ASTM  F2119-07 (Reapproved 2013)
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Scope/Abstract
1.1 This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or external power). Anything not established to be MR-Safe or MR-Conditional is excluded.
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 FDA Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued on August 21, 2008
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM107708.pdf

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/OSPTI/ORR/DSCA
  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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