Ophthalmic instruments - Eye refractometers (ISO 10342:1997)

Specification of minimum requirements in order to guarantee a sufficient quality of use

Ophthalmische Instrumente - Augenrefraktometer (ISO 10342:1997)

Diese Internationale Norm legt zusammen mit ISO 15004 Anforderungen und Prüfverfahren für Augenrefraktometer fest. Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004.

Instruments ophtalmiques - Réfractometres (ISO 10342:1997)

Oftalmični instrumenti - Očesni refraktometri (ISO 10342:1997)

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
Withdrawal Date
31-Aug-2003
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Sep-2003
Due Date
01-Sep-2003
Completion Date
01-Sep-2003

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SLOVENSKI STANDARD
SIST EN ISO 10342:2000
01-januar-2000
2IWDOPLþQLLQVWUXPHQWL2þHVQLUHIUDNWRPHWUL ,62
Ophthalmic instruments - Eye refractometers (ISO 10342:1997)
Ophthalmische Instrumente - Augenrefraktometer (ISO 10342:1997)
Instruments ophtalmiques - Réfractometres (ISO 10342:1997)
Ta slovenski standard je istoveten z: EN ISO 10342:1999
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10342:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10342:2000

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SIST EN ISO 10342:2000

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SIST EN ISO 10342:2000

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SIST EN ISO 10342:2000

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SIST EN ISO 10342:2000

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SIST EN ISO 10342:2000
INTERNATIONAL ISO
STANDARD 10342
First edition
1997-10-01
Ophthalmic instruments -
Eye ref ractometers -
Instruments ophtalmiques - ßkfractomefres
Reference number
ISO 10342: 1997(E)

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SIST EN ISO 10342:2000
EO 10342: 1997(E)
Foreword
ISO (the International Organization for Standardization) is a worldwidc
federation of national Standards bodies (ISO member bodies). The work of
preparing International Standards is normally carried out through ISO
technical committees. Esch 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 patt 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 10342 was prepared by ISO/TC 172, Optics
and Optical instruments, Subcommittee SC 7, Ophthalmic optics and
ins trumen ts.
Annex A forms an integral patt of this International Standard.
0 ISO 1997
All rights reserved. Unless othetwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronie or mechanical, including photocopying and
microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-121 1 Geneve 20 l Switzerland
Internet central@ iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii

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SIST EN ISO 10342:2000
ISO 10342:1997( E)
INTERNATIONAL STANDARD 0 ISO
Ophthalmic instruments - Eye refractometers
1 Scope
This International Standard, together with ISO 15004, specifies requirements and test
methods for eye refractometers.
This International Standard takes precedence over ISO 15004, if differentes 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 indicated below.
Members of IEC and ISO maintain registers of currently valid International Standards.
)
ISO 7944: -1) Optics and Optical instruments - ßeference wavelengths.
ISO 8429: 1986, Optics and Optical instruments - Ophthalmology - Graduated dial scale.
ISO 13666: -2) , Ophthalmic optics - Spectacle lenses - Vocabulary.
-2) Ophthalmic instruments - General requirements and test methods.
ISO 15004: ,
IEC 601-1: 1988, Medical electrical equipment - Parf 1: General requirements for safety.
3 Definitions
For the purposes of this International Standard, the definitions given in ISO 13666 and
the following definition apply.
Instrument with continuous or digital readout used for
3.1 eye refractometer:
measuring the refractive errors of the eye.
4 Requirements
4.1 General
The eye refractometer shall conform to the general requirements specified in
ISO 15004.
1) To be published. (Revision of ISO 7944:1984)
2) To be published.

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SIST EN ISO 10342:2000
ISO 10342: 1997(E)
42 . Optical requirements
The eye refractometer shall conform to the requirements given in table l or table 2.
The dioptric powers indicated in the requirements shall be referenced to the
wavelengths h = 546,07 nm or h = 58756 nm as required in ISQ 7944.
If the requirements arc not met for both wavelengths, the reference wavelength used
shall be indicated.
The indication of the readings of cylinder power shall be possible in plus or minus
cylinder convention.
Table 1 - Requirements for continuously indicating eye refractometers
Accuracy -
Criterion Measuring range Maximum double
scale interval
Standard
deviation
Spherical and cylindrical 0,25 D
+ 0,25 D
vertex power
0,50 D
+ 0,50 D
Cylinder 0,25 D to 0,50 D
+ IO”
axis ‘)
0
for
’ 0,50 D to 3,00 D 0” to 180” 5
- + 5”
cylinder
power > 3,00 D
+ 3”
-
i
*) Cylinder axis shall be indicated as specified in ISO 8429.
Table 2 - Requirements for digitally indicating eye refractometers
Deviation from
Criterion Measuring range Maximum
the nominal
scale interval
value of the
test device
Spherical and cylindrical 0,OO D to i: IO,00 D
0,25 D 2 0,25 D
vertex power
> IO,00 D 0,50 D 2 0,50 D
(absolute)
Cylinder 0,25 D to 0,50 D
+ IO”
-
axis ‘)
for > 0,50 D to 3,00 D
0” to 180” 2 5”
1 0
cylinder
!
power 3,00 D
> + 3”
*) Cylinder axis shall be indicated as specified in ISO 8429.
1
2

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SIST EN ISO 10342:2000
@ ISO
ISO 10342:1997(E)
43 l Measuring range
The eye refractometer shall have a minimum measuring range for vertex power of -15 D
to +15 D.
Eye refractometers which indicate cylindrical power shall have a minimum measuring
range for cylinder power of 0 D to 6 D.
The eye refractometer shal
...

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