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BS EN ISO 19980:2021 – TC:2022 Edition

BS EN ISO 19980:2021 – TC:2022 Edition

$186.33

Tracked Changes. Ophthalmic instruments. Corneal topographers

Published By Publication Date Number of Pages
BSI 2022 70
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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.

PDF Catalog

PDF Pages PDF Title
42 National foreword
44 European foreword
46 Foreword
47 1 Scope
2 Normative references
3 Terms and definitions
50 3.8 Curvature
3.8.1 Axial curvature
54 3.16 Surface
4 Requirements
4.1 Area measured
55 4.2 Measurement sample density
4.3 Measurement and report of performance
4.4 Colour presentation of results
5 Test methods and test devices
5.1 Tests
5.1.1 Accuracy test
5.1.2 Repeatability test
5.2 Test surfaces
5.2.1 Reflection-based and Placido ring corneal topographers
5.2.2 Luminous surface corneal topographer
5.2.3 Optical-sectioning corneal topographer
56 5.2.4 Specification of test surfaces
5.2.5 Verification of test surfaces
5.2.6 Type testing of surfaces
57 5.3 Data collection — Test surfaces
5.4 Analysis of the data
5.4.1 General
58 5.4.2 Structure of the accuracy data set
5.4.3 Analysis of the paired data sets
59 5.4.4 Report of accuracy performance
6 Accompanying documents
7 Marking
60 Annex A (informative) Test surfaces for corneal topographers (CTs)
62 Annex B (informative) Standardized displays for corneal topographers (CTs)
65 Annex C (normative) Calculation of area-weighting values
67 Annex D (normative) Test methods for measuring human corneas
68 Bibliography

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BS EN ISO 19980:2021 - TC
$186.33