Recognized standard
Z80.36-2021
FDA recognition 10-130 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-130 |
|---|---|
| Designation | Z80.36-2021 |
| Title | American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all current ophthalmic instruments that direct optical radiation into or at the eye. It is also applicable to all new and emerging ophthalmic instruments that direct optical… |
At a glance
- 10–99 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: