Recognized standard
Z80.30-2018
FDA recognition 10-113 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-113 |
|---|---|
| Designation | Z80.30-2018 |
| Title | American National Standard for Ophthalmics - Toric Intraocular Lenses |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard applies to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia. This standard addresses the… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: