Recognized standard
Z80.37-2017 (R2021)
FDA recognition 10-117 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-117 |
|---|---|
| Designation | Z80.37-2017 (R2021) |
| Title | American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This American National Standard, together with ISO 15004-1 and ANSI Z80.36, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. This American National Standard is not applicable to microscope… |
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: