SIST EN ISO 10943:2000
(Main)Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:1998)
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:1998)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:1998)
Diese Internationale Norm legt zusammen mit ISO 15004 Mindestanforderungen und Prüfverfahren für indirekte Ophtalmoskope in Form von Handgeräten, Geräten vom Brillentyp und am Kopf getragenen Geräten fest, die dazu dienen, indirekte Bilder des Augenhintergrundes zu beobachten. Diese Norm gilt nicht für Ophthalmoskopierlinsen und Zubehör. Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004.
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:1998)
Oftalmični instrumenti - Indirektni oftalmoskopi (ISO 10943:1998)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10943:2000
01-januar-2000
2IWDOPLþQLLQVWUXPHQWL,QGLUHNWQLRIWDOPRVNRSL ,62
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:1998)
Ophthalmische Instrumente - Indirekte Ophthalmoskope (ISO 10943:1998)
Instruments ophtalmiques - Ophtalmoscopes indirects (ISO 10943:1998)
Ta slovenski standard je istoveten z: EN ISO 10943:1998
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10943:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10943:2000
INTERNATIONAL ISO
STANDARD 10943
First edition
1998-05-01
Ophthalmic instruments — Indirect
ophthalmoscopes
Instruments ophtalmiques — Ophtalmoscopes indirects
A
Reference number
ISO 10943:1998(E)
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SIST EN ISO 10943:2000
ISO 10943:1998(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.
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.
International Standard ISO 10943 was prepared by Techncial Committee
ISO/TC 172, Optics and optical instruments, Subcommittee SC 7,
Ophthalmic optics and instruments.
Annex A forms an integral part of this International Standard. Annexes B
and C are for information only.
© ISO 1998
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 10943:2000
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INTERNATIONAL STANDARD ISO ISO 10943:1998(E)
Ophthalmic instruments — Indirect ophthalmoscopes
1 Scope
This International Standard, together with ISO 15004, specifies minimum requirements and test methods for hand-held,
spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This International Standard takes precedence over ISO 15004, if differences exist.
This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This International Standard 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.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standards. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility
of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of
currently valid International Standards.
ISO 15004:1997,
Ophthalmic instruments — Fundamental requirements and test methods
IEC 60601-1:1988,
Medical electrical equipment — Part 1: General requirements for safety
3 Définitions
For the purposes of this International Standard, the following definitions apply.
3.1
indirect ophthalmoscope
optical instrument used with a condensing lens (hand-held or integral) to examine the eye, particularly the media and
the fundus, by producing a real intermediate image which is viewed by the observer
3.2
monocular indirect ophthalmoscope
monocular ophthalmoscope which provides an illumination system and which is used with a condensing lens (hand-
held or integral) in order to direct appropriately focused light into the patient's eye
NOTE - Such instruments may include corrective lenses or eyepieces to aid focusing by the observer of the real
intermediate image produced by the condensing lens.
1
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ISO 10943:1998(E)
3.3
binocular indirect ophthalmoscope
binocular ophthalmoscope which provides an illumination system and which is used with a condensing lens in order to
direct appropriately focused light into the patient's eye
NOTE 1 Such instruments also include a viewing system which allows the observer to examine the patient's retina by
binocularly viewing the real intermediate image produced by the condensing lens.
NOTE 2 Such instruments may include corrective lenses or eyepieces to aid focusing of this image which is viewed
by the observer.
3.4
condensing lens
plus-power lens used to condense the illuminating beam into the patient’s eye and to form a real inverted image of the
retina thus illuminated
4 Requirements
4.1 General
The indirect ophthalmoscope shall conform to the requirements specified in ISO 15004.
The indirect ophthalmoscope shall conform to the specific requirements described in 4.2 to 4.4.
These requirements are verified as described in clause 5.
4.2 Optical and dimensional requirements
The requirements specified in table 1 and table 2 shall apply.
Table 1 — Optical and dimensional requirements where applicable
Criterion Requirement
Interpupillary distance range 55 mm to 72 mm
1) 2)
Diameter 2r of the field of view ≥ 100 mm
1)
Diameter of largest illuminated spot ≤ 45 mm
Range of adjustment of headband size 520 mm to 640 mm
1) At 500 mm distance from the light exit.
2)
2
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Table 2 — Requirements for optical accuracy where applicable
Criterion Tolerance
Vertical Interpupillary distance between < 10'
60 mm and 66 mm
Difference in
Interpupillary distance between 55 mm and < 15'
axes' orientation
60 mm and between 66 mm and 72 mm
between
left and right
Horizontal Divergence in parallel systems < 10'
optical systems
Convergence in parallel systems; in < 45'
convergent systems deviation from the
indicated angle
Difference in magnification between left and right systems, where provided < 5 %
Specified power of eyepieces or lenses where provided ± 0,09 D
4.3 Construction and function
4.3.1 The light output of the indirect ophthalmoscope shall be at least adjustable between the maximum and 10 % of
the maximum.
4.3.2 The illuminance without a condensing lens and without filters at 500 mm distance from the exit aperture of the
indirect ophthalmoscope shall be not less than 200 lx. Instruments with an integral condensing lens shall have
equivalent illuminance.
4.3.3 No reflections or scattered light shall be visible.
o
4.3.4 The illumination system shall be capable of alignment with the viewing system to within 1 vertically.
4.3.5 No difference in brightness or colour between the left and right optical system shall be visible.
4.4 Optical radiation hazard with indirect ophthalmoscopes
4.4.1 General
This clause replaces clauses 32, 33 and 34 of IEC 60601-1:1988.
4.4.2 Limit values
The limit values given in items a) and b) shall apply to the radiation emerging from the indirect ophthalmoscope
used to illuminate and view the human eye with light from 380 nm to 700 nm and in which the full beam
homogeneously illuminates a circular pupil of 8 mm (see notes 2 and 5).
NOTE 1 The limit values are considered acceptable with respect to the risks when weighted against the
performances intended.
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a) Short wavelength limit: The amount of radiant power exiting the indirect ophthalmoscope in the portion of the
2
spectrum from 305 nm to 400 nm shall have an irradiance no greater than 0,05 mW/cm as measured in the
1)
corneal plane when the instrument is operating at maximum intensity and, if the aperture can be varied, at
maximum aperture.
b) Long wavelength limit: The amount of energy exiting the indirect ophthalmoscope in the wavelength range 700 nm
2
to 1100 nm shall not exceed 100 mW/cm , nor shall it exceed the amount of energy exiting the indirect
ophthalmoscope in the range between 380 nm and 700 nm. The energy shall be measured in the corneal plane
when the instrument is operating at maximum intensity and maximum aperture.
NOTE 2 If, due to stops or other obstructions of the beam, a circular pupil of less than 8 mm diameter is illuminated,
the limit values may be increased by the ratio of the area of an 8 mm diameter pupil divided by the true area
illuminated.
NOTE 3 It is recommended that the energy in the range of the spectrum below 420 nm be attenuated as much as
possible.
NOTE 4 For indirect ophthalmoscopes with a large illuminating solid angle Ω over the designated spectral range
305 nm to 400 nm, i.e. Ω > 0,031 sr, the limit values may be increased by the ratio of the true solid angle, expressed
in steradians, divided by 0,031.
NOTE 5 For indirect ophthalmoscopes the assumptions used to set the limit value for radiation of wavelength
shorter than 400 nm are based on considerations of the typical spectral distribution of a 3000 K standard black body
source, an illuminating solid angle at the corneal plane of 0,031 sr, a maximum exposure time of 5 min and the
weighting factors for L (see Annex A). The limit is set to ensure that the fraction of the photochemical hazard dose
A
due to radiation of wavelength shorter than 400 nm is no greater than 1/8 of the total photochemical hazard dose
over all wavelengths when that total dose is at the threshold limit for an 8 mm diameter pupil.
Using the American Conference of Governmental Industrial Hygienists (ACGIH) guidelines, that threshold limit is
2
14J/( cm · sr). To convert from photochemical hazard weighted radiance to irradiance over the designated spectral
range 305 nm to 400 nm, the conversion factor 0,276 is used. Thus the limit is then found by the formula
2 2
[14 J/(cm · sr)] x (0,031 sr) x [0,276/(300 s · 8)] = 0,05 mW/cm .
4.4.3 Variable brightness
For indirect ophthalmoscopes where provision is made to vary the brightness, the manufacturer shall provide
indications for the proportion of the maximum intensity.
4.4.4 Particular information
The manufacturer shall provide the user with a graph showing the relative spectral output of the indirect
ophthalmoscope between 305 nm and 1100 nm when the instrument is operating at maximum
...
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