Recognized standard
16971-1 First edition 2024-11
FDA recognition 10-138 · ISO · Ophthalmic
Key facts
| Recognition number | 10-138 |
|---|---|
| Designation | 16971-1 First edition 2024-11 |
| Title | Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye. This document specifies characteristics and minimum requirements for OCT instruments and… |
At a glance
- None 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: