Recognized standard
F2504-05 (Reapproved 2022)
FDA recognition 4-136 · ASTM · Dental/ENT
Key facts
| Recognition number | 4-136 |
|---|---|
| Designation | F2504-05 (Reapproved 2022) |
| Title | Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
| Standards developer | ASTM International |
| Specialty area | Dental/ENT |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | 1.1 This practice defines means for describing system performance (ex vivo) and, in particular, system output of an implantable middle ear hearing device (IMEHD) by measuring a physical quantity that is relevant to the insertion gain and output level of the IMEHD when implanted in the patient. 1.2… |
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: