眼科设备.角膜外形测量系统

[中文适用范围]： 本文件规定了角膜地形图仪 (CT) 类仪器和系统的最低要求。 它还指定了测试和程序，以验证系统或仪器是否符合本文件，从而符合本文件规定的 CT 资格。 它还指定了允许验证超出 CT 最低要求的系统功能的测试和程序。 本文件定义了特定于角膜形状特征的术语，以便它们可以在整个视力护理领域中标准化。 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表面曲率、表面的三维地形测量或用于表征表面的其他更全局的参数。 本文件不适用于归类为检眼镜的眼科仪器。 [外文原描述]： 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.