Recognized standard
11979-2 Third edition 2024-10
FDA recognition 10-137 · ISO · Ophthalmic
Key facts
| Recognition number | 10-137 |
|---|---|
| Designation | 11979-2 Third edition 2024-10 |
| Title | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | May 26, 2025 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor 'IOL' used throughout this document also includes phakic intraocular lenses (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: