Recognized standard
13212 Third edition 2014-09-01
FDA recognition 10-97 · ISO · Ophthalmic
Key facts
| Recognition number | 10-97 |
|---|---|
| Designation | 13212 Third edition 2014-09-01 |
| Title | Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This International Standard provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products. This International Standard does not address studies designed to obtain information to establish the in-use… |
At a glance
- None 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: