| NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 12-232 |
| Extent | Complete standard |
| Standards Orgs | NEMA National Electrical Manufacturers Association https://www.nema.org/ |
| STG | Radiology |
| FDA Tech | Ting Song FDA/OMPT/CDRH/OIR/DRH/MREP/ 301-796-7677 ting.song@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1000 | Coil, Magnetic Resonance, Specialty | Class 2 | MOS |
| §892.1000 | System, Nuclear Magnetic Resonance Imaging | Class 2 | LNH |
| §892.1000 | System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | LNI |
| Guidance for Industry Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998 |