SIST EN ISO 10942:2022
(Main)Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
This document, 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 document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
Ophthalmische Instrumente - Direkte Ophthalmoskope (ISO 10942:2022)
Diese Internationale Norm legt zusammen mit ISO 15004-1 und ISO 15004-2 Mindestanforderungen und Prüfverfahren für direkte Ophthalmoskope in Form von Handgeräten fest, die dazu dienen, den Hintergrund des Auges im aufrechten Bild zu beobachten.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1 und ISO 15004-2.
Instruments ophtalmiques - Ophtalmoscopes directs (ISO 10942:2022)
Le présent document, conjointement avec l’ISO 15004-1 et l’ISO 15004-2, spécifie les exigences minimales et les méthodes d'essai relatives aux ophtalmoscopes directs de maniement manuel, conçus pour l'observation directe du fond de l'œil.
Le présent document prévaut sur l’ISO 15004-1 et l’ISO 15004-2, lorsque des différences existent.
Oftalmični instrumenti - Direktni oftalmoskopi (ISO 10942:2022)
Ta dokument skupaj s standardoma ISO 15004-1 in ISO 15004-2 določa minimalne zahteve in preskusne metode za ročne direktne oftalmoskope za neposredno opazovanje očesnega ozadja. V primeru razlik ima ta dokument prednost pred standardoma ISO 15004-1 in ISO 15004-2.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10942:2022
01-april-2022
Nadomešča:
SIST EN ISO 10942:2006
Oftalmični instrumenti - Direktni oftalmoskopi (ISO 10942:2022)
Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2022)
Ophthalmische Instrumente - Direkte Ophthalmoskope (ISO 10942:2022)
Instruments ophtalmiques - Ophtalmoscopes directs (ISO 10942:2022)
Ta slovenski standard je istoveten z: EN ISO 10942:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10942:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10942:2022
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SIST EN ISO 10942:2022
EN ISO 10942
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 10942:2006
English Version
Ophthalmic instruments - Direct ophthalmoscopes (ISO
10942:2022)
Instruments ophtalmiques - Ophtalmoscopes directs Ophthalmische Instrumente - Direkte Ophthalmoskope
(ISO 10942:2022) (ISO 10942:2022)
This European Standard was approved by CEN on 16 January 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10942:2022 E
worldwide for CEN national Members.
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SIST EN ISO 10942:2022
EN ISO 10942:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10942:2022
EN ISO 10942:2022 (E)
European foreword
This document (EN ISO 10942:2022) 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 August 2022, and conflicting national standards shall
be withdrawn at the latest by August 2022.
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 10942:2006.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 10942:2022 has been approved by CEN as EN ISO 10942:2022 without any modification.
3
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SIST EN ISO 10942:2022
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SIST EN ISO 10942:2022
INTERNATIONAL ISO
STANDARD 10942
Third edition
2022-01
Ophthalmic instruments — Direct
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes directs
Reference number
ISO 10942:2022(E)
© ISO 2022
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SIST EN ISO 10942:2022
ISO 10942:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
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SIST EN ISO 10942:2022
ISO 10942:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.2 Optical requirements . 2
5.3 Construction and function of the viewing system. 3
5.4 Construction and function of the illumination system . 3
5.5 Optical radiation hazard with direct ophthalmoscopes . 4
6 Test methods . 4
6.1 General . 4
6.2 Checking the optical and functional requirements . 4
7 Accompanying documents . .5
8 Marking . . 5
Bibliography . 6
iii
© ISO 2022 – All rights reserved
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SIST EN ISO 10942:2022
ISO 10942:2022(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 adh
...
SLOVENSKI STANDARD
oSIST prEN ISO 10942:2021
01-maj-2021
Oftalmični instrumenti - Direktni oftalmoskopi (ISO/DIS 10942:2021)
Ophthalmic instruments - Direct ophthalmoscopes (ISO/DIS 10942:2021)
Ophthalmische Instrumente - Direkte Ophthalmoskope (ISO/DIS 10942:2021)
Instruments ophtalmiques - Ophtalmoscopes directs (ISO/DIS 10942:2021)
Ta slovenski standard je istoveten z: prEN ISO 10942
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 10942:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10942:2021
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oSIST prEN ISO 10942:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10942
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-03-22 2021-06-14
Ophthalmic instruments — Direct ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes directs
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10942:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 10942:2021
ISO/DIS 10942:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 10942:2021
ISO/DIS 10942:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.2 Optical requirements . 3
5.3 Construction and function of the viewing system . 3
5.4 Construction and function of the illumination system . 3
5.5 Optical radiation hazard with direct ophthalmoscopes . 4
6 Test methods . 4
6.1 General . 4
6.2 Checking the optical and functional requirements . . 4
7 Accompanying documents . 5
8 Marking . 6
Bibliography . 7
© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 10942:2021
ISO/DIS 10942:2021(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.
This third edition cancels and replaces the second edition (ISO 10942:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Revision of the dated references;
— Editorial update of the whole document.
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
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oSIST prEN ISO 10942:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 10942:2021(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 documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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
ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods — Part 2:
Light hazard protection
I EC 6
...
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