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 systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document.

NOTE            In this document the term OCT refers to ophthalmic applications.