Recognized standard
18189 First edition 2016-06-01
FDA recognition 10-101 · ISO · Ophthalmic
Key facts
| Recognition number | 10-101 |
|---|---|
| Designation | 18189 First edition 2016-06-01 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Sep 21, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions. |
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: