Recognized standard
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020)
FDA recognition 4-204 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-204 |
|---|---|
| Designation | S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) |
| Title | American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This American National Standard specifies a test signal designed to represent normal speech, the International Speech Test Signal (ISTS), together with the procedures and the requirements for measuring the characteristics of signal processing in air-conduction hearing aids. The measurements are used… |
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: