Recognized standard
S12.2-2019
FDA recognition 4-260 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-260 |
|---|---|
| Designation | S12.2-2019 |
| Title | American National Standard for Criteria for Evaluating Room Noise |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 1, Class 3 |
| Scope (excerpt) | The three primary methods for evaluating room noise are: 1. The survey method that employs the A-weighted sound level; 2. The engineering method that employs noise criteria (NC) curves; and 3. The method for evaluating low-frequency fluctuating noise using room noise criteria (RNC) curves. This… |
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: