Recognized standard
16672 Third edition 2020-06
FDA recognition 10-121 · ISO · Ophthalmic
Key facts
| Recognition number | 10-121 |
|---|---|
| Designation | 16672 Third edition 2020-06 |
| Title | Ophthalmic implants - Ocular endotamponades |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3 |
| Scope (excerpt) | This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and… |
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: