Recognized standard
Z80.38-2017 (R2021)
FDA recognition 10-118 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-118 |
|---|---|
| Designation | Z80.38-2017 (R2021) |
| Title | American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | ANSI Z80.38 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery. NOTE - General requirements for operation microscopes and test methods for these requirements are specified in ISO 10936-1. |
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: