EN ISO 19980:2021
(Main)Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
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.
Ophthalmische Instrumente - Hornhauttopographen (ISO 19980:2021)
Dieses Dokument legt die Mindestanforderungen an Instrumente und Systeme, die in die Klasse der Hornhauttopographen (en: corneal topographer, CT) fallen, fest. Es definiert auch die Prüfungen und Verfahren zum Nachweis, dass ein System oder Instrument diesem Dokument entspricht und somit als Hornhauttopograph nach diesem Dokument gilt. Es legt weiterhin Prüfungen und Verfahren fest, die die Überprüfung der Fähigkeiten von Systemen erlauben, die über den Mindestanforderungen für Hornhauttopographen liegen.
Dieses Dokument legt Begriffe fest, die im Zusammenhang mit der Charakterisierung der Hornhaut-oberfläche eine spezielle Bedeutung haben und für die sich daher eine genormte Festlegung für das gesamte Gebiet der Augenheilkunde anbietet.
Dieses Dokument ist anwendbar für Instrumente, Systeme und Prüfverfahren, deren Zweck in der Vermessung der Oberflächenform der Hornhaut eines menschlichen Auges liegt.
ANMERKUNG Diese Messungen können Messungen der Oberflächenkrümmung in bestimmten Bereichen, drei¬dimensionale topographische Messungen der Oberfläche oder anderer, globaler Parameter, die eine Oberfläche charakterisieren, sein.
Dieses Dokument ist nicht anwendbar für ophthalmische Instrumente, die in die Klasse der Ophthalmometer fallen.
Instruments ophtalmiques - Topographes de la cornée (ISO 19980:2021)
Le présent document spécifie les exigences minimales relatives aux instruments et systèmes classés parmi les topographes cornéens (TC). Il spécifie également les essais et modes opératoires permettant de vérifier la conformité d'un système ou d'un instrument au présent document, et de le définir comme étant un TC au sens du présent document. Il spécifie en outre les essais et modes opératoires permettant de vérifier les aptitudes des systèmes dépassant les exigences minimales relatives aux TC.
Le présent document définit les termes spécifiques à la caractérisation de la forme de la cornée, de façon à pouvoir les normaliser dans l'ensemble du domaine des soins ophtalmologiques.
Le présent document concerne les instruments, systèmes et méthodes de mesure de la forme de la cornée de l'œil humain.
NOTE Il peut s'agir de mesurages de la courbure de la surface des zones locales, de mesurages topographiques à trois dimensions de la surface ou d'autres paramètres plus généraux utilisés pour caractériser la surface.
Le présent document ne s'applique pas aux instruments ophtalmiques classés parmi les ophtalmomètres.
Oftalmični instrumenti - Topografi roženice (ISO 19980:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 19980:2012
Oftalmični instrumenti - Topografi roženice (ISO 19980:2021)
Ophthalmic instruments - Corneal topographers (ISO 19980:2021)
Ophthalmische Instrumente - Hornhauttopographen (ISO 19980:2021)
Instruments ophtalmiques - Topographes de la cornée (ISO 19980:2021)
Ta slovenski standard je istoveten z: EN ISO 19980:2021
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19980
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 19980:2012
English Version
Ophthalmic instruments - Corneal topographers (ISO
19980:2021)
Instruments ophtalmiques - Topographes de la cornée Ophthalmische Instrumente - Hornhauttopographen
(ISO 19980:2021) (ISO 19980:2021)
This European Standard was approved by CEN on 6 June 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19980:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 19980:2021) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 19980:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 19980:2021 has been approved by CEN as EN ISO 19980:2021 without any modification.
INTERNATIONAL ISO
STANDARD 19980
Third edition
2021-06
Ophthalmic instruments — Corneal
topographers
Instruments ophtalmiques — Topographes de la cornée
Reference number
ISO 19980:2021(E)
©
ISO 2021
ISO 19980:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 19980:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 9
4.1 Area measured . 9
4.2 Measurement sample density . 9
4.3 Measurement and report of performance . 9
4.4 Colour presentation of results . 9
5 Test methods and test devices . 9
5.1 Tests . 9
5.1.1 Accuracy test . 9
5.1.2 Repeatability test . 9
5.2 Test surfaces . 9
5.2.1 Reflection-based and Placido ring corneal topographers . 9
5.2.2 Luminous surface corneal topographer .10
5.2.3 Optical-sectioning corneal topographer.10
5.2.4 Specification of test surfaces .10
5.2.5 Verification of test surfaces .10
5.2.6 Type testing of surfaces .10
5.3 Data collection — Test surfaces .11
5.4 Analysis of the data .11
5.4.1 General.11
5.4.2 Structure of the accuracy data set.12
5.4.3 Analysis of the paired data sets .12
5.4.4 Report of accuracy performance .13
6 Accompanying documents .13
7 Marking .13
Annex A (informative) Test surfaces for corneal topographers (CTs) .14
Annex B (informative) Standardized displays for corneal topographers (CTs) .16
Annex C (normative) Calculation of area-weighting values .19
Annex D (normative) Test methods for measuring human corneas .21
Bibliography .22
ISO 19980:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 19980:2012), which has been technically
revised. The main changes compared to the previous edition are as follows:
a) normative references were updated;
b) 5.2.6 regarding requirements for test surfaces and requirement for testing of accuracy was
changed;
c) in 5.4.3, formulae for data analysis have been updated;
d) Table 4 was deleted;
e) document editorially revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
INTERNATIONAL STANDARD ISO 19980:2021(E)
Ophthalmic instruments — Corneal topographers
1 Scope
This document specifies minimum requirements for instruments and systems
...
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