Recognized standard
18259 First Edition 2014-10-01
FDA recognition 10-100 · ISO · Ophthalmic
Key facts
| Recognition number | 10-100 |
|---|---|
| Designation | 18259 First Edition 2014-10-01 |
| Title | Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and… |
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: