Recognized standard
11979-6 Third edition 2014-10-01
FDA recognition 10-95 · ISO · Ophthalmic
Key facts
| Recognition number | 10-95 |
|---|---|
| Designation | 11979-6 Third edition 2014-10-01 |
| Title | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 3 |
| Scope (excerpt) | This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage. |
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: