Recognized standard
S3.4-2007 (Reaffirmed 2020)
FDA recognition 4-162 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-162 |
|---|---|
| Designation | S3.4-2007 (Reaffirmed 2020) |
| Title | American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | This standard specifies a procedure for calculating the monaural and binaural loudness of steady sounds as perceived by listeners with normal hearing. The procedure is based on the spectra of the sounds. The possible sounds include simple and complex tones (both harmonic and inharmonic), bands of… |
At a glance
- None 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: