Recognized standard
11981 Third edition 2017-11
FDA recognition 10-111 · ISO · Ophthalmic
Key facts
| Recognition number | 10-111 |
|---|---|
| Designation | 11981 Third edition 2017-11 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible. |
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: