SIST EN ISO 10942:2006

SLOVENSKI STANDARD
SIST EN ISO 10942:2006
01-september-2006
1DGRPHãþD
SIST EN ISO 10942:2000
SIST EN ISO 10942:2000/AC:2003
2IWDOPLþQLLQVWUXPHQWL±'LUHNWQLRIWDOPRVNRSL,62
Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006)
Ophthalmische Instrumente - Direkte Ophthalmoskope (ISO 10942:2006)
Instruments ophtalmiques - Ophtalmoscopes directs (ISO 10942:2006)
Ta slovenski standard je istoveten z: EN ISO 10942:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10942:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10942:2006

---------------------- Page: 2 ----------------------

SIST EN ISO 10942:2006
EUROPEAN STANDARD
EN ISO 10942
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.70 Supersedes EN ISO 10942:1998
English Version
Ophthalmic instruments - Direct ophthalmoscopes (ISO
10942:2006)
Instruments ophtalmiques - Ophtalmoscopes directs (ISO Ophthalmische Instrumente - Direkte Ophthalmoskope
10942:2006) (ISO 10942:2006)
This European Standard was approved by CEN on 9 March 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10942:2006: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 10942:2006

EN ISO 10942:2006 (E)





Foreword


This document (EN ISO 10942:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.

This document supersedes EN ISO 10942:1998.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.


Endorsement notice

The text of ISO 10942:2006 has been approved by CEN as EN ISO 10942:2006 without any
modifications.

2

---------------------- Page: 4 ----------------------

SIST EN ISO 10942:2006

INTERNATIONAL ISO
STANDARD 10942
Second edition
2006-06-01


Ophthalmic instruments — Direct
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes directs





Reference number
ISO 10942:2006(E)
©
ISO 2006

---------------------- Page: 5 ----------------------

SIST EN ISO 10942:2006
ISO 10942:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.


©  ISO 2006
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.
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 2006 – All rights reserved

---------------------- Page: 6 ----------------------

SIST EN ISO 10942:2006
ISO 10942:2006(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 10942 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 10942:1998 and ISO 10942:1998/Cor.1:1998),
which has been technically revised.


© ISO 2006 – All rights reserved iii

---------------------- Page: 7 ----------------------

SIST EN ISO 10942:2006

---------------------- Page: 8 ----------------------

SIST EN ISO 10942:2006
INTERNATIONAL STANDARD ISO 10942:2006(E)

Ophthalmic instruments — Direct ophthalmoscopes
1 Scope
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements
and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus.
This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, 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, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General
requirements applicable to all ophthalmic instruments
1)
ISO 15004-2:— , Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light
hazard protection
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
ophthalmoscope
optical instrument used to examine the external and internal parts of the eye, particularly the media and the
fundus
3.2
direct ophthalmoscope
ophthalmoscope which provides an illuminating system, an observation system and viewing lenses which allow
the observer to visualize the patient's eye directly, that is without the formation of an intermediate image
3.3
viewing lens
lens which is positioned betwee
...