Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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8-153
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Standard | |
ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
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Scope/Abstract1.1 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. |
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Extent of Recognition
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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. |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |