EN ISO 10944:2009
(Main)Ophthalmic instruments - Synoptophores (ISO 10944:2009)
Ophthalmic instruments - Synoptophores (ISO 10944:2009)
ISO 10944:2009, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze.
ISO 10944:2009 takes precedence over ISO 15004-1, if differences exist.
Ophthalmische Instrumente - Synoptophore (ISO 10944:2009)
Diese Internationale Norm legt zusammen mit ISO 15004-1 Mindestanforderungen und Prüfverfahren für
Synoptophore (auch als Synoptometer oder große Amblyoskope bezeichnet) fest, die dazu dienen, das
Binokularsehen eines Prüflings zu prüfen, zu messen, zu schulen und zu entwickeln, sowie Horizontal-,
Vertikal- und Zykloabweichungen für verschiedene Blickrichtungen zu messen.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1.
Instruments ophtalmiques - Synoptophores (ISO 10944:2009)
L'ISO 10944:2009 spécifie, conjointement à l'ISO 15004-1, les exigences minimales et les méthodes d'essai relatives aux synoptophores (également appelés amblyoscopes ou synoptomètres) utilisés pour tester, mesurer, entraîner et développer la vision binoculaire du patient, et pour mesurer les déviations horizontales et verticales ainsi que les déviations de la cyclophorie dans les différentes directions du regard.
L'ISO 10944:2009 prévaut sur l'ISO 15004-1 lorsque des différences existent.
Oftalmični instrumenti - Sinoptofori (ISO 10944:2009)
General Information
- Status
- Published
- Publication Date
- 31-Jul-2009
- Withdrawal Date
- 27-Feb-2010
- 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
- 01-Aug-2009
- Completion Date
- 01-Aug-2009
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
Overview
EN ISO 10944:2009 is the international and European standard specifying the minimum requirements and test methods for synoptophores, also known as major amblyoscopes or synoptometers. These ophthalmic instruments are essential for assessing, measuring, training, and developing a patient’s binocular vision. The standard defines how synoptophores should function to measure horizontal, vertical, and cyclo deviation across various gaze positions. EN ISO 10944:2009 takes precedence over ISO 15004-1 where differences occur, ensuring consistent quality and safety in clinical eye care.
Developed by ISO technical committee ISO/TC 172 in cooperation with CEN’s TC 170 on ophthalmic optics, the standard sets forth precise mechanical, optical, and functional criteria to ensure accurate and reliable synoptophore performance.
Key Topics
Scope and Purpose
- Specifies requirements for synoptophores used in testing binocular vision and eye alignment deviations.
- Covers optical, mechanical, and construction criteria essential for device accuracy and patient comfort.
Definitions
- Synoptophore: An instrument presenting adjustable, interchangeable visual targets to each eye independently.
- Visual targets: Includes images for simultaneous perception, fusion, and stereoscopic vision testing.
- Arms: Rotatable parts carrying ocular systems and targets, adjustable per patient needs.
Technical Requirements
- Interpupillary distance adjustment: 45 mm to 75 mm with graduations finer than 1 mm.
- Horizontal arm movement: ±40° independently adjustable.
- Vertical arm rotation: elevation up to 15°, depression up to 20°.
- Cyclotorsion movement: ±20° with 1° graduation.
- Chin-rest height adjustable between 75 mm and 125 mm relative to eyepiece centers.
- Construction allows compensation for refractive errors with precise lens holder placement.
Functional Specifications
- Easy insertion and removal of visual targets, clearly marked for identity and orientation.
- Uniform luminance and illumination control, including independent dimming and switching off of ocular illumination systems.
- Arms lockable together for synchronized movement or operated independently for precise measurements.
- Sets of visual targets to test simultaneous perception, fusion, and stereoscopic acuity.
- Minimization of contrast differences due to internal reflections or scattered light.
Testing and Verification
- Verification through type testing using accurate measuring instruments (angular precision ±5′ or better).
- Specific methods to check interpupillary distance, alignment of ocular axes, and chin-rest height.
- Tests and measurements to guarantee compliance with mechanical and optical tolerances.
Documentation and Marking
- Must include manufacturer's name, model, and compliance reference to ISO 10944:2009.
- Provide user instructions covering disinfection procedures, transport packaging compliance, and maintenance.
- Markings conform to IEC 60601-1 requirements for medical electrical equipment.
Applications
EN ISO 10944:2009 applies primarily to clinical and research settings where synoptophores are used for:
- Diagnosing and managing binocular vision disorders such as amblyopia, strabismus, and cyclodeviation.
- Training and rehabilitating binocular vision through controlled target presentation and vergence exercises.
- Objective measurement of eye misalignment in various gaze positions for accurate treatment planning.
- Quality assurance and manufacturing consistency for ophthalmic instrument producers.
- Ensuring patient safety and measurement accuracy in ophthalmology and optometry practices.
Compliance with this standard enables eye care professionals to rely on synoptophores that meet stringent optical, mechanical, and functional specifications, enhancing diagnostic and therapeutic outcomes.
Related Standards
- ISO 15004-1:2006 - Ophthalmic instruments - Fundamental requirements and test methods, Part 1: General requirements for all ophthalmic instruments. EN ISO 10944:2009 takes precedence in case of any differences.
- IEC 60601-1:2005 - Medical electrical equipment - General requirements for basic safety and essential performance; applicable for the electrical safety and performance of synoptophores.
- ISO 9801 - Ophthalmic instruments - Trial case lenses; relevant for lens holder specifications in synoptophores.
Adherence to EN ISO 10944:2009 alongside these complementary standards ensures comprehensive safety, performance, and interoperability of ophthalmic synoptophore instruments globally.
Keywords: EN ISO 10944:2009, synoptophore standards, ophthalmic instruments, binocular vision testing, amblyoscope requirements, synoptometer, medical eye equipment, ophthalmic optics standards, eye alignment measurement, ISO synoptophore test methods, ophthalmic instrument safety.
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Frequently Asked Questions
EN ISO 10944:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic instruments - Synoptophores (ISO 10944:2009)". This standard covers: ISO 10944:2009, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze. ISO 10944:2009 takes precedence over ISO 15004-1, if differences exist.
ISO 10944:2009, together with ISO 15004-1, specifies minimum requirements and test methods for synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of gaze. ISO 10944:2009 takes precedence over ISO 15004-1, if differences exist.
EN ISO 10944:2009 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 10944:2009 has the following relationships with other standards: It is inter standard links to EN ISO 10944:1998, EN 1911-1:1998, EN ISO 3175-1:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10944:2009 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-november-2009
1DGRPHãþD
SIST EN ISO 10944:2000
2IWDOPLþQLLQVWUXPHQWL6LQRSWRIRUL ,62
Ophthalmic instruments - Synoptophores (ISO 10944:2009)
Ophthalmische Instrumente - Synoptophore (ISO 10944:2009)
Instruments ophtalmiques - Synoptophores (ISO 10944:2009)
Ta slovenski standard je istoveten z: EN ISO 10944:2009
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 10944
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 11.040.70 Supersedes EN ISO 10944:1998
English Version
Ophthalmic instruments - Synoptophores (ISO 10944:2009)
Instruments ophtalmiques - Synoptophores (ISO Ophthalmische Instrumente - Synoptophore (ISO
10944:2009) 10944:2009)
This European Standard was approved by CEN on 31 July 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10944:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 10944:2009) 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 February 2010, and conflicting national standards shall be withdrawn
at the latest by February 2010.
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 10944:1998.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10944:2009 has been approved by CEN as a EN ISO 10944:2009 without any modification.
INTERNATIONAL ISO
STANDARD 10944
Second edition
2009-08-01
Ophthalmic instruments —
Synoptophores
Instruments ophtalmiques — Synoptophores
Reference number
ISO 10944:2009(E)
©
ISO 2009
ISO 10944:2009(E)
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ISO 10944:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10944 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 10944:1998), which has undergone minor
revision in order to update normative references.
INTERNATIONAL STANDARD ISO 10944:2009(E)
Ophthalmic instruments — Synoptophores
1 Scope
This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for
synoptophores (also called major amblyoscopes or synoptometers) used to test, measure, train and develop
the patient's binocular vision and to measure horizontal, vertical and cyclo deviation in different positions of
gaze.
This International Standard takes precedence over ISO 15004-1, if differences exist.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 15004-1:2006, Ophthalmic instruments — Fundamental requirements and test methods — Par
...
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