SIST EN ISO 9801:2010

SLOVENSKI STANDARD
01-marec-2010
1DGRPHãþD
SIST EN ISO 9801:2000
2IWDOPLþQLLQVWUXPHQWL3RVNXVQHOHþH,62
Ophthalmic instruments - Trial case lenses (ISO 9801:2009)
Ophthalmische Instrumente - Refraktionsgläser (ISO 9801:2009)
Instruments ophtalmiques - Verres de boîte d'essai (ISO 9801:2009)
Ta slovenski standard je istoveten z: EN ISO 9801:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 9801
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2009
ICS 11.040.70 Supersedes EN ISO 9801:1999
English Version
Ophthalmic instruments - Trial case lenses (ISO 9801:2009)
Instruments ophtalmiques - Verres de boîte d'essai (ISO Ophthalmische Instrumente - Refraktionsgläser (ISO
9801:2009) 9801:2009)
This European Standard was approved by CEN on 4 December 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 9801:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 9801:2009) 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 June 2010, and conflicting national standards shall be withdrawn at
the latest by June 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 9801:1999.
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 9801:2009 has been approved by CEN as a EN ISO 9801:2009 without any modification.

INTERNATIONAL ISO
STANDARD 9801
Second edition
2009-12-15
Ophthalmic instruments — Trial case
lenses
Instruments ophtalmiques — Verres de boîte d'essai

Reference number
ISO 9801:2009(E)
©
ISO 2009
ISO 9801:2009(E)
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ii © ISO 2009 – All rights reserved

ISO 9801:2009(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 requirements.2
4.3 Construction .4
4.4 Material and surface quality .5
5 Test methods .5
5.1 General .5
5.2 Checking the optical requirements .5
5.3 Checking material and surface quality.6
5.4 Checking construction.6
6 Functional marking .6
7 Information supplied by the manufacturer .6
7.1 Accompanying documents.6
7.2 Identification of the trial case lens set .7
Annex A (informative) Example of test device for checking accuracy of trial case lens elements.8
Annex B (informative) Example of test device and method for checking material and surface
quality .10
Bibliography.11

ISO 9801:2009(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 9801 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 9801:1997), which has undergone a minor
revision to update normative references and to include a second standard diameter (see 4.3.2).

iv © ISO 2009 – All rights reserved

INTERNATIONAL STANDARD ISO 9801:2009(E)

Ophthalmic instruments — Trial case lenses
1 Scope
This International Standard specifies requirements for mounted ophthalmic full and/or reduced aperture trial
case lenses for the determination of the refractive error of the eye.
This International Standard takes priority over ISO 15004-1, 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 7944, Optics and optical instruments — Reference wavelengths
ISO 13666, Ophthalmic optics — Spectacle lenses — Vocabulary
ISO 15004-1:2006, Ophthalmic instruments — Fundamental requirements and test methods — Part 1:
General requirements applicable to all ophthalmic instruments
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13666 and the following apply.
3.1
trial case lens
lens, in a mount, used to assess the refractive error of the human eye
3.2
full-aperture trial case lens
trial case lens with a protective mount of maximal practical wall thickness of approximately 1 mm, allowing the
maximum available free lens aperture
3.3
reduced-aperture trial case lens
trial case lens with the designated free lens aperture significantly less than the mount outer diameter, allowing
for considerable reductions in lens thicknesses to be made
3.4
additive power trial case lens set
train of spherical, cylindrical or spherocylindrical combination of trial case lenses, in which the measured back-
vertex power at the last surface equals the meridional sums of the labelled values of the train lenses when
each element is placed in its specified frame cell
NOTE See ISO 12867.
ISO 9801:2009(E)
3.5
lens power
〈spherical lens〉 back-vertex power, expressed in dioptres (D)
3.6
lens power
〈cylindrical lens〉 back-vertex power in the principal meridian not equal to zero, expressed in dioptres (D)
NOTE Cylindrical trial case lenses have one principal meridian with zero power.
3.7
prismatic power
〈prismatic lens, prism〉 prismatic effect, measured as the displacement, in centimetres, of the light ray in a
plane perpendicular to its line of incidence on the lens at a distance of 1 m
NOTE 1 Prism
...