Recognized standard
11979-7 Fifth edition 2024-01
FDA recognition 10-135 · ISO · Ophthalmic
Key facts
| Recognition number | 10-135 |
|---|---|
| Designation | 11979-7 Fifth edition 2024-01 |
| Title | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | May 29, 2024 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. |
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: