Recognized standard
S3.1-1999 (Reaffirmed 2023)
FDA recognition 4-160 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-160 |
|---|---|
| Designation | S3.1-1999 (Reaffirmed 2023) |
| Title | American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | Hearing measurements in an audiometric test room may be conducted for different audiometric purposes over different test frequency ranges. However, if the ambient noise level is excessively high, some hearing threshold levels measured in that environment will be inaccurate. This occurs because… |
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: