EN ISO 10343:2014
(Main)Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
ISO 10343:2009, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006, 4.1. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.
ISO 10343:2009 takes priority over ISO 15004-1, if differences exist.
Ophthalmische Instrumente - Ophthalmometer (ISO 10343:2014)
Diese Internationale Norm legt zusammen mit ISO 15004-1 Anforderungen und Prüfverfahren für kontinuier-lich oder digital anzeigende Ophthalmometer fest. Einige Typen von Ophthalmometern bieten hinreichende Auflösung und Messbereich (Tabelle 2), so dass sie auch geeignet sind, die Krümmungsradien von Kontakt-linsen gemäß den Anforderungen von ISO 18369-3:2006, 4.1.3 und Abschnitt 5, zu messen. Es wird vorausgesetzt, dass die lokale Vorderfläche der Hornhaut und beide Oberflächen der Kontaktlinse sphärisch oder torisch sind.
Diese Internationale Norm hat Vorrang vor ISO 15004-1, wenn Unterschiede vorliegen.
Instruments ophtalmiques - Ophtalmomètres (ISO 10343:2014)
L'ISO 10343:2009, conjointement à l'ISO 15004-1, spécifie les exigences et les méthodes d'essai relatives aux ophtalmomètres à indication continue ou numérique. Certains types d'ophtalmomètres permettent de mesurer les rayons de courbure des lentilles de contact conformément à l'ISO 18369-3:2006, 4.1. Il est admis que la surface locale avant de la cornée, ainsi que les surfaces des lentilles de contact sont sphériques ou toroïdales.
L'ISO 10343:2009 prévaut sur l'ISO 15004-1, dans le cas où une différence existe.
Oftalmični instrumenti - Oftalmometri (ISO 10343:2014)
Standard EN ISO 10343 skupaj s standardom ISO 15004-1 določa zahteve in preskusne metode za trajne ali digitalne oftalmometre. Določeni tipi oftalmometrov imajo zadostno ločljivost in razpon (glej preglednico 2) za pravilno merjenje premera ukrivljenosti kontaktne leče, ki ustreza točkama 4.1.3 in 5 standarda ISO 18369-3:2006. Predvideva se, da so sprednja površina roženice in obe površini kontaktne leče sferične ali torične. Ta mednarodni standard ima prednost pred standardom ISO 15004-1, če so med njima razlike.
General Information
- Status
- Published
- Publication Date
- 01-Jul-2014
- Withdrawal Date
- 30-Jan-2015
- Technical Committee
- CEN/TC 170 - Ophthalmic optics
- Drafting Committee
- CEN/TC 170 - Ophthalmic optics
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 02-Jul-2014
- Completion Date
- 02-Jul-2014
Relations
- Effective Date
- 09-Jul-2014
- Effective Date
- 28-Jan-2026
Overview
EN ISO 10343:2014 - Ophthalmic instruments - Ophthalmometers is the CEN-adopted version of ISO 10343:2014. It specifies requirements and type-test methods for continuously or digitally indicating ophthalmometers used to measure the radii of curvature and principal meridians of the cornea and, for higher-resolution instruments, contact lenses. The standard assumes local corneal and contact-lens surfaces are spherical or toroidal and takes precedence over ISO 15004-1 where conflicts exist.
Key topics and technical requirements
- Measurement range: instruments must cover 6.5 mm to 9.4 mm (approx. 52.0 KD to 36.0 KD).
- Instrument types:
- Type A - higher resolution suitable for contact lenses and corneas: continuous scale interval 0.02 mm, digital increment 0.02 mm, measurement accuracy ±0.025 mm (2σ).
- Type B - for human corneas: continuous scale interval 0.1 mm, digital increment 0.02 mm, measurement accuracy ±0.05 mm (2σ).
- Meridian (axis) measurement: angular range 0°–180°; continuous scale interval 5°, digital increment 1°. Accuracy depends on meridional curvature difference: ±4° (≤0.3 mm) and ±2° (>0.3 mm).
- Eyepiece adjustment: distance-dependent instruments must have dioptric adjustment at least −4 D to +4 D, with −3 D to +2 D calibrated.
- Test methods and type testing: conformity is verified using precise spherical/toroidal test surfaces and test devices with tight surface tolerances (e.g., sphere uncertainty ≤1 µm). Measuring devices used for verification must have errors <10% of the smallest value measured.
- Documentation & marking: instruments must be accompanied by instructions (including disinfection and transport info) and be permanently marked with manufacturer, model, serial number, type (A/B) and a reference to ISO 10343:2014 if claimed.
Practical applications and users
- Manufacturers of ophthalmometers and keratometers - to design, validate and CE-mark devices to meet European/ISO requirements.
- Clinical equipment test laboratories - performing type tests, calibration and verification against ISO 10343 criteria.
- Optical labs and contact-lens manufacturers - using Type A instruments for contact-lens curvature measurement compliant with ISO 18369-3.
- Ophthalmologists and optometrists - selecting instruments with specified accuracy and axis-measurement performance for corneal diagnostics and fitting.
- Regulatory and procurement teams - specifying compliance with EN ISO 10343:2014 in tenders and conformity assessments.
Related standards
- ISO 15004-1 - general ophthalmic instrument requirements (EN ISO 10343 takes priority if differences occur).
- ISO 18369-3 - contact-lens specifications (relevant for Type A ophthalmometers).
- ISO 8429, IEC 60601-1 - referenced for angular notation, safety and accompanying documentation.
This standard is essential for ensuring consistent, traceable keratometry, curvature measurement and axis determination in ophthalmic instruments and devices.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN ISO 10343:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)". This standard covers: ISO 10343:2009, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006, 4.1. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal. ISO 10343:2009 takes priority over ISO 15004-1, if differences exist.
ISO 10343:2009, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006, 4.1. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal. ISO 10343:2009 takes priority over ISO 15004-1, if differences exist.
EN ISO 10343:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 10343:2014 has the following relationships with other standards: It is inter standard links to EN ISO 10343:2009, EN 1911-1:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10343:2014 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2014
1DGRPHãþD
SIST EN ISO 10343:2009
2IWDOPLþQLLQVWUXPHQWL2IWDOPRPHWUL ,62
Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
Ophthalmische Instrumente - Ophthalmometer (ISO 10343:2014)
Instruments ophtalmiques - Ophtalmomètres (ISO 10343:2014)
Ta slovenski standard je istoveten z: EN ISO 10343:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10343
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.70 Supersedes EN ISO 10343:2009
English Version
Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
Instruments ophtalmiques - Ophtalmomètres (ISO Ophthalmische Instrumente - Ophthalmometer (ISO
10343:2014) 10343:2014)
This European Standard was approved by CEN on 24 April 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10343:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 10343:2014) 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 January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10343:2009.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10343:2014 has been approved by CEN as EN ISO 10343:2014 without any modification.
INTERNATIONAL ISO
STANDARD 10343
Third edition
2014-07-01
Ophthalmic instruments —
Ophthalmometers
Instruments ophtalmiques — Ophtalmomètres
Reference number
ISO 10343:2014(E)
©
ISO 2014
ISO 10343:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 10343:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Radius of curvature measurements . 2
4.3 Measurement of direction of principal meridians. 3
4.4 Eyepiece adjustment (if applicable) . 3
5 Test methods . 3
5.1 General . 3
5.2 Checking optical requirements . 3
6 Accompanying documents . 4
7 Marking, labelling and packaging . 4
Annex A (informative) Test devices and test configuration for checking meridional axesand
ophthalmometer position . 5
Bibliography . 7
ISO 10343:2014(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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...