Recognized standard
9394 Third edition 2012-10-01
FDA recognition 10-77 · ISO · Ophthalmic
Key facts
| Recognition number | 10-77 |
|---|---|
| Designation | 9394 Third edition 2012-10-01 |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in… |
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: