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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 062 Date of Entry 05/29/2024 
FR Recognition Number 12-354
Standard
NEMA  MS 4-2023
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Scope/Abstract
This standard specifies all the information necessary to determine, declare, and verify airborne emission sound pressure level characteristics of MR EQUIPMENT under standardized conditions in the MR EXAMINATION ROOM. It specifies minimum requirements for measurement methods and operating conditions that shall be used for the test. This standard measures the maximum exposure the PATIENT may experience and the representative average MR EQUIPMENT output at the position for an MR WORKER standing beside the PATIENT table.

The use of this standard ensures the reproducibility of the measured airborne noise-emission characteristics within specified limits determined by the grade of accuracy of the basic airborne noise measurement methods used. Noise measurement methods according to this standard are engineering
methods (grade 2). All measurements as defined in this standard are acceptable for ISO 4871 declarations. Translation to sound power levels is not required for the purpose of this standard.
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.
Transition Period
FDA recognition of NEMA MS 4-2010 [Rec# 12-232] will be superseded by recognition of NEMA MS 4-2023 [Rec# 12-354]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-232] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 12-232] will not be accepted.
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*
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued Oct. 2023.

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
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-0478
  Daniel.Krainak@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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