EN ISO 10341:1999
(Main)Ophthalmic instruments - Refractor heads (ISO 10341:1997)
Ophthalmic instruments - Refractor heads (ISO 10341:1997)
Specification of minimum requirements in order to guarantee a sufficient qualityof use
Ophthalmische Instrumente - Phoropter (ISO 10341:1997)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für Phoropter fest, die zur Bestimmung von Refraktionsanomalien und Binokularfunktionen des menschlichen Auges benutzt werden. Diese Internationale Norm hat Vorrang vor ISO 15004, wenn Unterschiede vorliegen.
Instruments ophtalmiques - Têtes de réfracteurs (ISO 10341:1997)
La CEI 62341-5-3:2013 spécifie les conditions et les méthodes de mesure normalisées pour déterminer la durée de vie et la rémanence des images de modules et de panneaux d'affichage à diodes électroluminescentes organiques (OLED). Elle s'applique principalement à des modules.
Oftalmološki instrumenti - Glave refraktorjev (ISO 10341:1997)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10341:2000
01-januar-2000
Oftalmološki instrumenti - Glave refraktorjev (ISO 10341:1997)
Ophthalmic instruments - Refractor heads (ISO 10341:1997)
Ophthalmische Instrumente - Phoropter (ISO 10341:1997)
Instruments ophtalmiques - Tetes de réfracteurs (ISO 10341:1997)
Ta slovenski standard je istoveten z: EN ISO 10341:1999
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10341:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10341:2000
IS0
INTERNATIONAL
10341
STANDARD
First edition
1997-07- 15
Ophthalmic instruments - Refractor
heads
Instruments ophtalmiques - Tetes de kfracteurs
Reference number
IS0 10341 :I 997(E)
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SIST EN ISO 10341:2000
ISOlO341:1997(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
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. IS0
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 IS0 10341 was prepared by Technical Committee
ISOmC 172, Optics and optical instruments, Subcommittee SC 7,
Ophthalmic optics and instruments.
Annex A of this International Standard is for information only.
0 IS0 1997
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 l CH-1211 Geneve 20 l 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 10341:2000
ISO10341:1997( E)
INTERNATIONAL STANDARD o Iso
Ophthalmic instruments - Refractor heads
1 Scope
This International Standard specifies requirements and test methods for refractor heads used for the determination
of refractive errors and binocular functions of the human eye.
This International Standard takes priority over IS0 15004, if differences exist.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. 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 listed below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
---I), Optics and optical instruments - Reference wavelengths.
IS0 7944:
IS0 8429: 1986, Optics and optical instruments - Ophthalmology - Graduated dial scale.
IS0 13666: -2), Ophthalmic optics - Spectacle lenses - Vocabulary.
IS0 15004: --2), Ophthalmic instruments - Fundamental requirements and test methods.
IEC 601-I :I 988, Medical electrical equipment - Part 1: General requirements for safety.
3 Definitions
For the purposes of this International Standard, the definitions given in IS0 13666 and the following apply.
3.1 refractor head: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other
optical devices in front of a subject’s eyes for the purpose of determining refractive error and binocular functions.
3.2 reference plane: Plane at which the readings and the power tolerances of the refractor head apply.
3.3 reference distance: Distance between the reference plane of the refractor head and the cornea1 vertex.
1) To be published. (Revision of IS0 7944:1984)
2) To be published.
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SIST EN ISO 10341:2000
IS0 10341: 1997(E)
4 Requirements
4.1 General
The refractor head shall conform to the requirements specified in IS0 15004.
4.2 Measuring ranges
The requirements specified in table 1 for refractor heads shall apply.
Table I - Measuring ranges for refractor heads
\
Minimum measuring ranges for each side
Criterion
0 D to + 15 D in steps of 0,25 D
Spherical power
0 D to - 15 D in steps of 0,25 D
Astigmatic power 0 D to 5 D in steps of 0,25 D in plus or minus cylinder form.
Cylinder axis’) 0” to 180’ indicated in 5’ steps; in addition, readings or estimates to 1 O shall be
possible.
Prismatic power*) 0 A to IO A in steps of 1 A, or continuously.
Prism base’) 0” to 360” indicated in 5’ steps; in addition, readings or estimates to lo shall be
possible. Indication of the prism base by horizontal and vertical components is
allowed as an alternative.
Cylinder axis and prism base settings shall be indicated according to IS0 8429.
The combined prismatic powers of both sides shall be at least 30 A.
4.3 Optical requirements
The requirements specified in tables 2 to 7 shall apply. Powers shall be measured in the reference plane.
Conformance shall be verified as described in 5.1.
The dioptric powers indicated in tables 2, 3 and 5 shall be referenced to the wavelength A = 546,07 nm or
alternatively A = 587,56 nm in accordance with IS0 7944.
If the requirements are not met for both wavelengths, the reference wavelength used shall be indicated.
The requirements for spherical power are given in table 2.
Table 2 - Tolerances on spherical power
Tolerance on
Indicated spherical power
(absolute)
mean power residual astigmatism
Sl + S2
D
Is, 421
2
D
D
+ 0,06
0,oo to 3,00
+ 0,09
> 3,00 to 6,00
> 6,00 to 9,00 + 0,12 0,03
> 9,00 to 12,00 k 0,15
> 12,00 to 15,00 + 0,18
> 15,00
+ 0,25
L
NOTE - Sl and S2 refer to the vertex powers in the principal meridians.
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SIST EN ISO 10341:2000
@ IS0
IS0 10341:1997(E)
The requirements for cylindrical power are given in table 3.
Table 3 - Tolerances on cylindrical power
Indicated cylindrical power
Meridian of highest
absolute power D
G 0,50 > 0,50 to I,00 > l,OOto 3,00 > 3,00to 6,00 > 6,00
(nominal value)
Tolerance
D D
0,12
0,06 0,09
0,ooto 5,00
0,06
> 5,ooto IO,00
0,18
0,06 0,09 0,12
> 10,ooto 15,00
0,09 0,12 0,18 0,25
> 15,00
NOTE - The tolerance for the meridian with the higher absolute power, given in table 2, is valid for both meridians in addition to the
cylinder tolerances of table 3.
The requirements on centring of lens combinations are given in table 4.
Table 4 - Tolerances of prismatic effect of spherical
and cylindrical lenses relative to the centre point
of the aperture in the combined optical mechanical system
(not including crossed cylinders)
Indicated power
Tolerance
(absolute)
D A
0,12
0,oo
> 0,OOto 6,00 0,25
0,37
> 6,OOto 12,0
...
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