Recognized standard
Z80.21-2020
FDA recognition 10-127 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-127 |
|---|---|
| Designation | Z80.21-2020 |
| Title | American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard applies to displays of optotypes for all clinical visual acuity measurement systems that use recognition of optotypes and that are designed for general use including optotypes printed on opaque media, those intended for transillumination, electronically generated or projected displays… |
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: