Recognized standard
MS 4-2023
FDA recognition 12-354 · NEMA · Radiology
Key facts
| Recognition number | 12-354 |
|---|---|
| Designation | MS 4-2023 |
| Title | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
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: