Recognized standard
S3.5-1997 (Reaffirmed 2020)
FDA recognition 4-163 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-163 |
|---|---|
| Designation | S3.5-1997 (Reaffirmed 2020) |
| Title | American National Standard Methods for Calculation of the Speech Intelligibility Index |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | Defines a method for computing a physical measure that is highly correlated with the intelligibility of speech as evaluated by speech perception tests given a group of talkers and listeners. This measure is called the speech Intelligibility Index, SII. The SII is calculated from acoustical… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: