Recognized standard
11979-8 Third edition 2017-04
FDA recognition 10-105 · ISO · Ophthalmic
Key facts
| Recognition number | 10-105 |
|---|---|
| Designation | 11979-8 Third edition 2017-04 |
| Title | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants. |
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: