| ANSI Z80.21-2010 (R2015) American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 10-73 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Ophthalmic |
| FDA Tech | Bruce Drum FDA/OMPT/CDRH/ODE/DOED/DSDB/ 301-796-6466 bruce.drum@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard applies to displays of optotypes for all clinical visual acuity measurement systems thatuse recognition of high-contrast optotypes and that are designed for general use including optotypesprinted on opaque media, those intended for transillumination, electronically generated or projected displays.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.1150 | Chart, Visual Acuity | Class 1 | HOX |
| There is no relevant guidance developed at this time. |