Recognized standard
S3.45-2009 (Reaffirmed 2019)
FDA recognition 4-185 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-185 |
|---|---|
| Designation | S3.45-2009 (Reaffirmed 2019) |
| Title | American National Standard Procedures for Testing Basic Vestibular Function |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 27, 2015 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This Standard specifies procedures for conducting six separate tests, which, together with the data analysis and reporting requirements specified in this Standard, constitute the Basic Vestibular Function Test Battery. The six tests cover: (a) spontaneous nystagmus (see 5.2); (b) gaze-evoked… |
At a glance
- 1–9 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: