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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 034 Date of Entry 01/30/2014 
FR Recognition Number 12-264
Standard
NEMA  MS 11-2010
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
Scope/Abstract
This document defines methods for determining the gradient -induced electric fields of diagnostic magnetic resonance imaging gradient coils (head and body) under a specific set of conditions. This document does not address the effect of electrical inhomogeneities in the body on internal, gradient - induced, electric fields.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998

Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003

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
 Ting Song
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7677
  ting.song@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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