BS EN ISO 19980:2021
$142.49
Ophthalmic instruments. Corneal topographers
Published By | Publication Date | Number of Pages |
BSI | 2021 | 30 |
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.
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 |
---|---|
2 | National foreword |
4 | European foreword |
6 | Foreword |
7 | 1 Scope 2 Normative references 3 Terms and definitions |
10 | 3.8 Curvature 3.8.1 Axial curvature |
14 | 3.16 Surface 4 Requirements 4.1 Area measured |
15 | 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 |
16 | 5.2.4 Specification of test surfaces 5.2.5 Verification of test surfaces 5.2.6 Type testing of surfaces |
17 | 5.3 Data collection — Test surfaces 5.4 Analysis of the data 5.4.1 General |
18 | 5.4.2 Structure of the accuracy data set 5.4.3 Analysis of the paired data sets |
19 | 5.4.4 Report of accuracy performance 6 Accompanying documents 7 Marking |
20 | Annex A (informative) Test surfaces for corneal topographers (CTs) |
22 | Annex B (informative) Standardized displays for corneal topographers (CTs) |
25 | Annex C (normative) Calculation of area-weighting values |
27 | Annex D (normative) Test methods for measuring human corneas |
28 | Bibliography |