Recognized standard
S3.36-2012 (Reaffirmed 2022)
FDA recognition 4-217 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-217 |
|---|---|
| Designation | S3.36-2012 (Reaffirmed 2022) |
| Title | American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard describes a manikin which is intended to simulate the acoustical effects of a median human adult, including diffractions affecting the in-situ performance of electroacoustic devices used on or near a person. The manikin consists of a head mounted on a torso that extends to the waist… |
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: