|
SIST EN ISO 10940:2009
01-oktober-2009
1DGRPHãþD
SIST EN ISO 10940:2000
2IWDOPLþQLLQVWUXPHQWL.DPHUH]DVOLNDQMHRþHVQHJDR]DGMD ,62
Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
Ophthalmische Instrumente - Funduskameras (ISO 10940:2009)
Instruments ophtalmiques - Appareils photographiques du fond de l'oeil (ISO
10940:2009)
Ta slovenski standard je istoveten z: EN ISO 10940:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10940:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 10940:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 10940:2009
EUROPEAN STANDARD
EN ISO 10940
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 11.040.70 Supersedes EN ISO 10940:1998
English Version
Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
Instruments ophtalmiques - Appareils photographiques du Ophthalmische Instrumente - Funduskameras (ISO
fond de l'oeil (ISO 10940:2009) 10940:2009)
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 10940:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10940:2009
EN ISO 10940:2009 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 10940:2009
EN ISO 10940:2009 (E)
Foreword
This document (EN ISO 10940:2009) 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 10940:1998.
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 10940:2009 has been approved by CEN as a EN ISO 10940:2009 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 10940:2009
---------------------- Page: 6 ----------------------
SIST EN ISO 10940:2009
INTERNATIONAL ISO
STANDARD 10940
Second edition
2009-08-01
Ophthalmic instruments — Fundus
cameras
Instruments ophtalmiques — Appareils photographiques du fond de
l'œil
Reference number
ISO 10940:2009(E)
©
ISO 2009
---------------------- Page: 7 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(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.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2009
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 [email protected]
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Requirements . 2
4.1 General. 2
4.2 Optical properties . 2
4.3 Construction and function. 3
4.4 Optical radiation hazard with fundus cameras. 3
5 Test methods for checking the optical properties . 4
5.1 General. 4
5.2 Test target arrangement. 4
5.3 Checking the resolving power of the fundus camera optics . 5
5.4 Checking the angular field of view. 5
5.5 Checking the magnification of the image. 5
5.6 Checking the pixel pitch of a sensor on the fundus . 6
6 Accompanying documents. 6
7 Marking . 6
Annex A (normative) Guidance for the measurement and calculation of the light hazard related
values. 7
Annex B (informative) Guidance for safe use of the fundus camera. 12
© ISO 2009 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(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 10940 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 10940:1998) which has been technically
revised.
iv © ISO 2009 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 10940:2009
INTERNATIONAL STANDARD ISO 10940:2009(E)
Ophthalmic instruments — Fundus cameras
1 Scope
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test
methods for fundus cameras operating for observing, photographing or recording electronic images of the
fundus of the human eye in order to provide the image information for diagnosis. This International Standard is
not applicable to the following instruments:
⎯ those that contact the eye during the examination;
⎯ those using scanning laser sources.
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
ISO 15004-2:2007, 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
resolving power of the fundus camera optics on the fundus
minimum separation allowing recognition of two adjacent lines on the fundus, expressed as number of line
pairs per millimetre (lp/mm)
3.2
angular field of view
FOV
maximum image size displayed on the image plane, expressed as the angle subtended at the exit pupil of the
eye by the maximum dimension 2r
See Figure 1.
© ISO 2009 – All rights reserved 1
---------------------- Page: 11 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(E)
3.3
magnification of image
ratio of the size of an object at the centre on the image plane to that of the fundus, assuming that the eye is
emmetropic and that it has a focal length of 17 mm in air
3.4
pixel pitch on the fundus
distance between two pixels (from centre to centre) of a digital image sensor theoretically projected on to the
fundus, expressed in micrometres (µm), assuming that the eye is emmetropic and that it has a focal length of
17 mm in air
3.5
high eye point eyepiece
eyepiece in which the exit pupil is of sufficient clearance from the eyepiece to allow spectacles to be worn
Key
1 angular field of view
2 entrance pupil of instrument/exit pupil of eye
Figure 1 — Meaning of dimension r for various formats
4 Requirements
4.1 General
The fundus camera shall conform to the requirements specified in ISO 15004-1 and ISO 15004-2.
4.2 Optical properties
The fundus camera shall conform to the requirements given in Table 1.
When using near infrared light (NIR) for imaging (e.g. ICG application), the given limits for resolving power
shall be reduced by a factor of 1,6.
It is recommended that an oblique astigmatism compensator be provided for observation and recording
images of the periphery of the retina when using a fundus camera with an optical angular field u 30°.
2 © ISO 2009 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(E)
Table 1 — Requirements for optical properties
Criterion Requirement
centre W 80 lp/mm
Field of view
middle (r/2) W 60 lp/mm
u 30°
a
Resolving power on
periphery (r) W 40 lp/mm
the fundus for fundus
centre W 60 lp/mm
camera optics
Field of view
middle (r/2) W 40 lp/mm
> 30°
periphery (r) W 25 lp/mm
Tolerance of angular field of view ± 5 %
b
Tolerance of magnification of image ± 7 %
c
Tolerance of pixel pitch on fundus ± 7 %
− 5 D to + 5 D
Range of dioptre adjustment of the optical
− 4 D to + 4 D
finder (when an optical finder is attached)
for high eye point eyepieces
Range of focus adjustment for
− 15 D to + 15 D
compensation of patient's refractive error
a
To achieve the resolving power according this table, optical means are recommended. In the case
of recording images, it is necessary to choose an appropriate medium (film or digital sensor).
b
Only for fundus cameras recording on film.
c
Only for fundus cameras recording on a digital sensor.
4.3 Construction and function
4.3.1 General
The instrument shall be designed in such a way that neither reflection nor stray light degrades the image.
4.3.2 High eye point eyepiece
If the manufacturer states that the eyepiece is a high eye point eyepiece, the clearance shall be W 17 mm, as
measured from that part of the eyepiece nearest the examiner's eye to the exit pupil of the instrument.
4.4 Optical radiation hazard with fundus cameras
This clause replaces 10.5, 10.6 and 10.7 of IEC 60601-1:2005. Fundus cameras shall comply with the light
hazard protection requirements that are given in ISO 15004-2 in consideration of the following modality. (For
guidance, see Annex A.)
It shall first be determined if the fundus camera is classified as a group 1 or group 2 instrument in accordance
with ISO 15004-2:2007, Clause 4. The applicable clauses of ISO 15004-2:2007 for fundus cameras are as
follows.
a) For group 1 fundus cameras:
1) applicable requirements of ISO 15004-2:2007 are 5.1, 5.2 and 5.4 (except 5.4.3). For cameras with
multiple sources designed to direct optical radiation on to the same point(s) of the eye at the same
time, the following shall apply:
i) the optical radiation emissions shall be below all applicable limits for each light source alone;
ii) the resulting or combined radiation of the multiple sources shall be below all applicable limits of
ISO 15004-2:2007, Table 2 or Table 3;
© ISO 2009 – All rights reserved 3
---------------------- Page: 13 ----------------------
SIST EN ISO 10940:2009
ISO 10940:2009(E)
2) applicable test methods are given in ISO 15004-2:2007, 6.1, 6.2 and 6.4.
If status is determined to be group 1, there are no further requirements. If status is determined not to be
group 1, the additional requirements given in b) are applicable.
b) For group 2 fundus cameras:
1) applicable requirements of ISO 15004-2:2007 are 5.1, 5.3, 5.5 (except 5.5.3). For cameras with
multiple sources designed to direct optical radiation on to the same point(s) of the eye at the same
time the following shall apply:
i) the optical radiation emissions shall be below all applicable limits for each light source alone;
ii) the resulting or combined radiation of the multiple sources shall be below all applicable limits or
guideline values of ISO 15004-2:2007, Tables 4, 5 and 6;
iii) for intended consecutive and/or simultaneous use of pulsed and continuous light sources within
an 8 h period, the sum of the ratios of the optical radiation emitted over the specified wavelength
range according ISO 15004-2:2007, Tables 4, 5 and 6 to the applicable limit or guideline value
shall be less than one. Only ratios of the same kind, i.e. related to the same hazard
(e.g. photochemical, thermal or aphakic), shall be considered;
2) applicable test methods are given in ISO 15004-2:2007, 6.1, 6.2, 6.3, 6.4 and 6.5;
3) ISO 15004-2:2007, Clause 7.
If a fundus camera is capable of emitting more radiation in the visible or infrared wavelength range than
specified for group 2 instruments, the manufacturer shall inform the user in the user manual about the
potential hazard. See Annex B.
5 Test methods for checking the optical properties
5.1 General
All tests described in this International Standard are type tests.
The requirements specified in 4.2 shall be verified by use of measuri
...