Recognized standard
Z80.10-2014
FDA recognition 10-96 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-96 |
|---|---|
| Designation | Z80.10-2014 |
| Title | American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard, together with ISO 15004-1:2009, Fundamental requirements and test methods - Part 1: General requirements applicable to all instruments - First edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation… |
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: