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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 028 Date of Entry 03/16/2012 
FR Recognition Number 12-232
Standard
NEMA  MS 4-2010
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Scope/Abstract
The purpose of this NEMA Standards Publication is to provide methods to determine the acoustic noise level of an MR system. Two measurement procedures are defined, Maximum Gradient Acoustic Noise (MGAN) and Maximum Clinical Acoustic Noise (MCAN).

This procedure has been designed for measuring peak sound pressure levels (SPL) up to 140 dB. Above 140 dB, the use of more sophisticated equipment and methods may be required.
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

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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