Recognized standard
15752 Second edition 2010-01-15
FDA recognition 10-65 · ISO · Ophthalmic
Key facts
| Recognition number | 10-65 |
|---|---|
| Designation | 15752 Second edition 2010-01-15 |
| Title | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 2, 2011 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This International Standard specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery. |
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: