Recognized standard
Z80.7-2013 (R2018)
FDA recognition 10-89 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-89 |
|---|---|
| Designation | Z80.7-2013 (R2018) |
| Title | American National Standard for Ophthalmic Optics - Intraocular Lenses |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard applies to monofocal intraocular lenses (IOLs) whose primary indication is the correction of aphakia. This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, biocompatibility, sterility, shelf-life and transport stability… |
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: