Recognized standard
12865 Second edition 2006-07-01
FDA recognition 10-39 · ISO · Ophthalmic
Key facts
| Recognition number | 10-39 |
|---|---|
| Designation | 12865 Second edition 2006-07-01 |
| Title | Ophthalmic instruments - Retinoscopes |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 19, 2007 |
| Scope (excerpt) | This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye. This International Standard takes precedence over ISO 15004-1, if differences… |
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: