Recognized standard
S3.7-2016 (Reaffirmed 2023)
FDA recognition 4-273 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-273 |
|---|---|
| Designation | S3.7-2016 (Reaffirmed 2023) |
| Title | American National Standard Method for Coupler Calibration of Earphones |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This standard describes measurement methods for earphones and earphone transducers using couplers or ear simulators. Guidance is provided for the selection of the appropriate coupler or ear simulator for a given earphone and application. Methods for measurement of calibrated frequency response… |
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: