Recognized standard
11979-10 Second edition 2018-03
FDA recognition 10-133 · ISO · Ophthalmic
Key facts
| Recognition number | 10-133 |
|---|---|
| Designation | 11979-10 Second edition 2018-03 |
| Title | Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 3 |
| Scope (excerpt) | ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL)… |
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: