Recognized standard
10940 Second edition 2009-08-01
FDA recognition 10-74 · ISO · Ophthalmic
Key facts
| Recognition number | 10-74 |
|---|---|
| Designation | 10940 Second edition 2009-08-01 |
| Title | Ophthalmic instruments - Fundus cameras |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This… |
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: