Recognized standard
11979-1 Fourth edition 2018-11
FDA recognition 10-124 · ISO · Ophthalmic
Key facts
| Recognition number | 10-124 |
|---|---|
| Designation | 11979-1 Fourth edition 2018-11 |
| Title | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document. |
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: