Recognized standard
11986 Third edition 2017-11
FDA recognition 10-112 · ISO · Ophthalmic
Key facts
| Recognition number | 10-112 |
|---|---|
| Designation | 11986 Third edition 2017-11 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
| 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 provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses. NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic… |
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: