Recognized standard
S12.65-2006 (Reaffirmed 2020)
FDA recognition 4-177 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-177 |
|---|---|
| Designation | S12.65-2006 (Reaffirmed 2020) |
| Title | American National Standard For Rating Noise with Respect to Speech Interference |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | This standard defines a simple numerical method for rating the expected speech-interfering aspects of noise using acoustical measurements of the noise. The relevant acoustical characteristics of the noise are summarized in terms of a single-valued index known as the speech interference level. The… |
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: