本文件规定了角膜地形图仪（CTs）类仪器和系统的最低要求。它还规定了验证系统或仪器符合本文件要求的测试和程序，从而符合本文件规定的CT要求。它还规定了允许验证超出CTs最低要求的系统能力的测试和程序。 本文件定义了特定于角膜形状特征的术语，以便在整个视力护理领域对其进行标准化。 本文件适用于测量人眼角膜表面形状的仪器、系统和方法。 注？测量可以是局部区域的曲面曲率、曲面的三维地形测量或用于表征曲面的其他更全局的参数。 本文件不适用于归类为眼压计的眼科仪器。

This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE？The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.