EN ISO 10341:2012

SLOVENSKI STANDARD
01-marec-2013
1DGRPHãþD
SIST EN ISO 10341:2009
Oftalmološki instrumenti - Glave refraktorjev (ISO 10341:2012)
Ophthalmic instruments - Refractor heads (ISO 10341:2012)
Ophthalmische Instrumente - Phoropter (ISO 10341:2012)
Instruments ophtalmiques - Têtes de réfracteurs (ISO 10341:2012)
Ta slovenski standard je istoveten z: EN ISO 10341:2012
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 10341
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 11.040.70 Supersedes EN ISO 10341:2009
English Version
Ophthalmic instruments - Refractor heads (ISO 10341:2012)
Instruments ophtalmiques - Têtes de réfracteurs (ISO Ophthalmische Instrumente - Phoropter (ISO 10341:2012)
10341:2012)
This European Standard was approved by CEN on 14 January 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10341:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 10341:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
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 10341:2009.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 10341:2012 has been approved by CEN as a EN ISO 10341:2012 without any modification.

INTERNATIONAL ISO
STANDARD 10341
Third edition
2012-12-01
Ophthalmic instruments — Refractor heads
Instruments ophtalmiques — Têtes de réfracteurs
Reference number
ISO 10341:2012(E)
©
ISO 2012
ISO 10341:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 2012 – All rights reserved

ISO 10341:2012(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 10341 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 10341:2009), of which Tables 2, 3 and 4 have
been technically revised.
INTERNATIONAL STANDARD ISO 10341:2012(E)
Ophthalmic instruments — Refractor heads
1 Scope
This International Standard specifies requirements and test methods for refractor heads used for the
determination of refractive errors and binocular functions of the human eye.
This International Standard takes priority 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 7944, Optics and optical instruments — Reference wavelengths
ISO 8429, Optics and optical instruments — Ophthalmology — Graduated dial scale
ISO 13666, Ophthalmic optics — Spectacle lenses — Vocabulary
ISO 15004-1:2006, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General
requirements applicable to all ophthalmic instruments
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13666 and the following apply.
3.1
refractor head
instrument providing a means of positioning spherical and cylindrical lenses, prisms and other optical devices
in front of a subject’s eyes for the purpose of determining refractive error and binocular functions
3.2
reference plane
plane at which the readings and the power tolerances of the refractor head apply
3.3
reference distance
distance between the reference plane of the refractor head and the corneal vertex
4 Requirements
4.1 General
The refractor head shall conform to the requirements specified in ISO 15004-1.
4.2 Measuring ranges
The requirements specified in Table 1 for refractor heads shall apply.
ISO 10341:2012(E)
Table 1 — Measuring ranges for refractor heads
Criterion Minimum measuring ranges for each side
Spherical power 0 D to +15 D in steps of 0,25 D
0 D to −15 D in steps of 0,25 D
Astigmatic power 0 D to 5 D in steps of 0,25 D in plus or minus cylinder form
a
Cylinder axis 0° to 180° indicated in 5° steps; in addition, readings or estimates to 1° shall be possible
b
Prismatic power 0 Δ to 10 Δ in steps of 1 Δ, or continuously
a
Prism base 0° to 360° indicated in 5° steps; in addition, readings or estimates to 1° shall be possible.
Indication of the prism base by horizontal and vertical compo
...