Recognized standard
Z80.20-2016 (R2021)
FDA recognition 10-104 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-104 |
|---|---|
| Designation | Z80.20-2016 (R2021) |
| Title | American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | Applies to contact lenses worn over the front surface of the eye in contact with the preocular tear film. The standard covers rigid intracorneal and haptic (scleral) contact lenses, as well as soft paralimbal contact lenses. |
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: