SIST EN ISO 10943:2011
(Main)Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
ISO 10943:2011 specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
ISO 10943:2011 is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
ISO 10943:2011 is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2011)
Diese Internationale Norm legt zusammen mit ISO 15004-1 und ISO 15004-2 Mindestanforderungen und
Prüfverfahren für indirekte Ophthalmoskope in Form von Handgeräten, Geräten vom Brillentyp und am Kopf
getragenen Geräten fest, die dazu dienen, indirekte Bilder des Augenhintergrundes zu beobachten.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1 und ISO 15004-2.
Diese Internationale Norm gilt nicht für Ophthalmoskopierlinsen und Zubehör.
Diese Internationale Norm gilt nicht für Tischgeräte wie Gullstrand’sche Ophthalmoskope und ihre Abwandlungen
und auch nicht für Ophthalmoskope, die hauptsächlich zur Bildaufnahme und/oder -verarbeitung
bestimmt sind, wie solche, die auf der Laser-Scanning-Technik beruhen.
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2011)
L'ISO 10943:2011 spécifie les exigences minimales et les méthodes d'essai relatives aux ophtalmoscopes indirects à maniement manuel, de type lunettes portées sur la tête, conçus pour l'observation indirecte des images du fond de l'oeil.
L'ISO 10943:2011 ne s'applique pas aux lentilles de champ, ni aux accessoires utilisés en ophtalmoscopie indirecte.
L'ISO 10943:2011 ne s'applique pas aux instruments montés sur table tels que les ophtalmoscopes de Gullstrand, ni à leurs dérivés, ni encore aux ophtalmoscopes dont l'usage est principalement destiné à la saisie et/ou au traitement des images telles que celles obtenues avec les techniques de scannérisation au laser.
Oftalmični instrumenti - Indirektni oftalmoskopi (ISO 10943:2011)
Ta mednarodni standard skupaj z ISO 15004-1 in ISO 15004-2 določa minimalne zahteve in preskusne metode za ročne indirektne oftalmoskope v obliki očal, ki se nosijo na glavi, za opazovanje indirektnih slik očesnega ozadja. Ta mednarodni standard ima prednost pred ISO 15004-1 in ISO 1500-2, če so med njima razlike. Ta mednarodni standard ne velja za kondenzacijske leče, ki se uporabljajo za indirektno oftalmoskopijo, ali za dodatke. Ta mednarodni standard ne velja za instrumente, pritrjene na mizo, kot so Gullstrandovi oftalmoskopi in njihove izpeljanke, in ne za oftalmoskope, ki so predvsem namenjeni slikanju in/ali obdelavi, na primer oftalmoskope na osnovi laserskih tehnik slikanja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10943:2011
01-december-2011
1DGRPHãþD
SIST EN ISO 10943:2006
2IWDOPLþQLLQVWUXPHQWL,QGLUHNWQLRIWDOPRVNRSL ,62
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:2011)
Ta slovenski standard je istoveten z: EN ISO 10943:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10943:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10943:2011
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SIST EN ISO 10943:2011
EUROPEAN STANDARD
EN ISO 10943
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2011
ICS 11.040.70 Supersedes EN ISO 10943:2006
English Version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO
10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO Ophthalmische Instrumente - Indirekte Ophthalmoskope
10943:2011) (ISO 10943:2011)
This European Standard was approved by CEN on 14 August 2011.
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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10943:2011: E
worldwide for CEN national Members.
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SIST EN ISO 10943:2011
EN ISO 10943:2011 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 10943:2011
EN ISO 10943:2011 (E)
Foreword
This document (EN ISO 10943:2011) 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 2012, and conflicting national standards shall be withdrawn
at the latest by February 2012.
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 10943:2006.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10943:2011 has been approved by CEN as a EN ISO 10943:2011 without any modification.
3
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SIST EN ISO 10943:2011
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SIST EN ISO 10943:2011
INTERNATIONAL ISO
STANDARD 10943
Third edition
2011-08-15
Ophthalmic instruments — Indirect
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
Reference number
ISO 10943:2011(E)
©
ISO 2011
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SIST EN ISO 10943:2011
ISO 10943:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
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 2011 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10943:2011
ISO 10943:2011(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 10943 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 10943:2006), which has undergone a minor
revision to include:
⎯ updated normative references;
⎯ additional information concerning the necessary use of a condensing lens when testing for compliance
with light hazard requirements [second paragraph of 4.4 and list item e) of Clause 6].
© ISO 2011 – All rights reserved iii
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SIST EN ISO 10943:2011
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SIST EN ISO 10943:2011
INTERNATIONAL STANDARD ISO 10943:2011(E)
Ophthalmic instruments — Indirect ophthalmoscopes
1 Scope
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements
and test methods for hand-held, spectacle-type, and head-worn indirect ophthal
...
SLOVENSKI STANDARD
kSIST FprEN ISO 10943:2011
01-julij-2011
2IWDOPLþQLLQVWUXPHQWL,QGLUHNWQLRIWDOPRVNRSL ,62)',6
Ophthalmic instruments - Indirect ophthalmoscopes (ISO/FDIS 10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO/FDIS 10943:2011)
Ta slovenski standard je istoveten z: FprEN ISO 10943
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
kSIST FprEN ISO 10943:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN ISO 10943:2011
---------------------- Page: 2 ----------------------
kSIST FprEN ISO 10943:2011
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 10943
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.70 Will supersede EN ISO 10943:2006
English Version
Ophthalmic instruments - Indirect ophthalmoscopes (ISO/FDIS
10943:2011)
Instruments ophtalmiques - Ophtalmoscopes indirects
(ISO/FDIS 10943:2011)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 170.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 10943:2011: E
worldwide for CEN national Members.
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kSIST FprEN ISO 10943:2011
FprEN ISO 10943:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
kSIST FprEN ISO 10943:2011
FprEN ISO 10943:2011 (E)
Foreword
This document (FprEN ISO 10943:2011) 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 document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN ISO 10943:2006.
Endorsement notice
The text of ISO/FDIS 10943:2011 has been approved by CEN as a FprEN ISO 10943:2011 without any
modification.
3
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kSIST FprEN ISO 10943:2011
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kSIST FprEN ISO 10943:2011
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10943
ISO/TC 172/SC 7
Ophthalmic instruments — Indirect
Secretariat: DIN
ophthalmoscopes
Voting begins on:
2011-04-14
Instruments ophtalmiques — Ophtalmoscopes indirects
Voting terminates on:
2011-06-14
Please see the administrative notes on page iii
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 SUPPORT-
ING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 10943:2011(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2011
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kSIST FprEN ISO 10943:2011
ISO/FDIS 10943:2011(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2011 – All rights reserved
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kSIST FprEN ISO 10943:2011
ISO/FDIS 10943:2011(E)
ISO/CEN PARALLEL PROCESSING
This Minor Revision has been developed within the International Organization for Standardization (ISO),
and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This final draft is hereby submitted to a parallel two-month approval vote in ISO and three-month UAP vote
in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
© ISO 2011 – All rights reserved iii
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kSIST FprEN ISO 10943:2011
ISO/FDIS 10943:2011(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 10943 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 10943:2006), which has undergone a minor
revision to include:
⎯ updated normative references;
⎯ additional information concerning the necessary use of a
...
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