Recognized standard
11980 Third edition 2012-11-15 Corrected version 2012-12-01
FDA recognition 10-85 · ISO · Ophthalmic
Key facts
| Recognition number | 10-85 |
|---|---|
| Designation | 11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products. |
At a glance
- 10–99 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: