| ANSI Z80.10-2014 American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 10-96 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Within Annex B: -B.5.3 (Last paragraph) -B.5.5 -B.7.2 |
| 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 |
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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 of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.1930 | Tonometer, Ac-Powered | Class 2 | HKX |
| §886.1930 | Tonometer, Manual | Class 2 | HKY |
| Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions, Issued March 27, 2006. |