Recognized standard
MS 4-2010
FDA recognition 12-232 · NEMA · Radiology
Key facts
| Recognition number | 12-232 |
|---|---|
| Designation | MS 4-2010 |
| Title | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: