SIST EN ISO 8612:2010

SLOVENSKI STANDARD
SIST EN ISO 8612:2010
01-januar-2010
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SIST EN ISO 8612:2002
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Ophthalmic instruments - Tonometers (ISO 8612:2009)
Ophthalmische Instrumente - Augentonometer (ISO 8612:2009)
Instruments ophtalmiques - Tonomètres (ISO 8612:2009)
Ta slovenski standard je istoveten z: EN ISO 8612:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 8612:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8612:2010

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SIST EN ISO 8612:2010


EUROPEAN STANDARD
EN ISO 8612

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2009
ICS 11.040.70 Supersedes EN ISO 8612:2001
English Version
Ophthalmic instruments - Tonometers (ISO 8612:2009)
Instruments ophtalmiques - Tonomètres (ISO 8612:2009) Ophthalmische Instrumente - Augentonometer (ISO
8612:2009)
This European Standard was approved by CEN on 10 September 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 8612:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8612:2010
EN ISO 8612:2009 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 8612:2010
EN ISO 8612:2009 (E)
Foreword
This document (EN ISO 8612:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 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 8612:2001.
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 8612:2009 has been approved by CEN as a EN ISO 8612:2009 without any modification.

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SIST EN ISO 8612:2010

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SIST EN ISO 8612:2010

INTERNATIONAL ISO
STANDARD 8612
Second edition
2009-10-01


Ophthalmic instruments — Tonometers
Instruments ophtalmiques — Tonomètres





Reference number
ISO 8612:2009(E)
©
ISO 2009

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SIST EN ISO 8612:2010
ISO 8612:2009(E)
PDF disclaimer
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Published in Switzerland

ii © ISO 2009 – All rights reserved

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SIST EN ISO 8612:2010
ISO 8612:2009(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 Design compliance testing (certification).2
4.3 Verification (instrument compliance) .2
4.4 Construction and function.3
5 Test methods .3
6 Accompanying documents.3
7 Additional information .3
8 Marking.4
Annex A (normative) Reference tonometer and method for determining reference IOP.5
Annex B (normative) Design compliance testing.12

© ISO 2009 – All rights reserved iii

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SIST EN ISO 8612:2010
ISO 8612:2009(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 8612 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 8612:2001), which has been technically revised.

iv © ISO 2009 – All rights reserved

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SIST EN ISO 8612:2010
INTERNATIONAL STANDARD ISO 8612:2009(E)

Ophthalmic instruments — Tonometers
1 Scope
This International Standard, together with ISO 15004-1, specifies minimum requirements and the design
compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure
(IOP).
This International Standard takes precedence over ISO 15004-1, if differences exist.
NOTE The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the
true IOP cannot be clinically measured, alternative methods are specified for determining a reference IOP (Annex A and
Annex B).
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
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
intraocular pressure
IOP
pressure within the eye
NOTE It is expressed in millimetres of mercury (mmHg), where 1 mmHg = 0,133 3 kPa.
3.2
reference tonometer
tonometer as described in Annex A
3.3
test tonometer
verified tonometer used in design compliance testing
3.4
reference IOP
IOP that is measured with a reference tonometer, as specified in Annex A, in accordance with the procedures
given in Annex B
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SIST EN ISO 8612:2010
ISO 8612:2009(E)
3.5
measured IOP
IOP reading provided by the test tonometer when used in accordance with the manufacturer's instructions
4 Requirements
4.1 General
4.1.1 The test tonometer shall conform to the general requirements specified in ISO 15004-1.
4.1.2 The test tonometer shall conform to the specific requirements specified in 4.2 to 4.4.
4.2 Design compliance testing (certification)
4.2.1 The manufacturer shall demonstrate, on the basis of design compliance testing as specified in
Clause 5, that the test tonometer measurements, when compared to the reference tonometer measurements,
meet the requirements as given in Table 1.
A tonometer that meets the requirements of Annex A for a reference tonometer need not undergo design
compliance testing.
The requirements are met if not more than 5 % of the paired differences between the reference tonometer
reading and the test tonometer reading for each pressure range are greater than the tolerance for that range
in Table 1.
NOTE The tolerances given in Table 1 represent 1,96 times the standard deviation allowable for the paired
measurement, and so account for not only the allowable error of the tonometer under test but also unavoidable error
associated with the reference tonometer.
Table 1 — Requirements for tonometers
IOP range Tolerance Minimum number of eyes
mmHg mmHg
7 to16 ±5,0 40
> 16 to < 23 ±5,0 40
W 23 ±5,0 40
4.2.2 The manufacturer shall analyse the data, taken in the course of design compliance testing as
specified in Clause 5, using the total least squares method for the regression, and make available, as required
in Clause 7, the slope, the offset and the standard deviation of the regression line.
4.3 Verification (instrument compliance)
4.3.1 The manufacturer shall develop a method and test apparatus to confirm that the design requirements
of 4.2 are met by each manufactured tonometer. Each tonometer shall be verified with this method and
apparatus. This method and test apparatus shall be the same as those used to measure and verify the test
tonometer in 4.2.
4.3.2 The permissible error of the test apparatus shall be less than or equal to one-half of the permissible
tolerance as given in Table 1.
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SIST EN ISO 8612:2010
ISO 8612:2009(E)
4.4 Construction and function
4.4.1 The surfaces of the tonometer that are intended to come into contact with the cornea shall be:
a) composed of non-toxic, stable and non-oxidative material which is inert to ocular tissue, tears and
appropriate pharmacological agents;
b) designed either to facilitate disinfection or for single patient use;
c) free of surface irregularities and imperfections when viewed with unmagnified corrected vision.
4.4.2 The tonometer shall permit the measurement of IOP throughout the range 7 mmHg to 50 mmHg. The
scale or display shall either provide a direct measurement of a value whose relationship to IOP is known or
give a numerical reading corresponding to the IOP value.
Readings of IOP less than 7 shall be displayed either by their numerical value or by a “low reading” indication.
Readings of IOP greater than 50 shall be displayed either by their numerical value or by a “high reading”
indication.
5 Test methods
5.1 This International Standard describes type testing (certification) and individual device testing
(verification).
5.2 The reference IOP shall be determined as described in Annex A.
5.3 Design compliance testing shall be performed as described in Annex B.
6 Accompanying documents
The tonometer shall be accompanied by documents containing instructions for use together with maintenance
procedures and their frequency of application. In particular, this information shall contain:
a) name and address of the manufacturer;
b) instructions for effective disinfection of the tonometer where applicable;
c) contra-indications for the use of the tonometer;
d) a list of accessories suitable for use with the tonometer;
e) if appropriate, any additional documents as specified in 7.9 of IEC 60601-1:2005;
f) a reference to this International Standard, i.e. ISO 8612:2009, if the manufacturer or supplier claims
compliance with it.
7 Additional information
Upon request, the manufacturer shall provide information on the operating principles of the certified tonometer.
© ISO 2009 – All rights reserved 3

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SIST EN ISO 8612:2010
ISO 8612:2009(E)
8 Marking
The tonometer shall be permanently marked with at least the following information:
a) name of manufacturer or supplier;
b) name and model of tonometer;
c) if applicable, marking as required by IEC 60601-1.
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SIST EN ISO 8612:2010
ISO 8612:2009(E)
Annex A
(normative)

Reference tonometer and method for determining reference IOP
A.1 Specifications of the reference applanation tonometer
A.1.1 General
The reference tonometer shall be a mechanical-optical applanation tonometer that measures the force
required to produce a given area of applanation.
A.1.2 Area of applanation
The area of applanation shall be circular with a diameter of 3,06 mm. The manufacturing tolerance for the
diameter of the applanation circle shall be ±0,02 mm.
A.1.3 Surface of tonometer head
The front (contact) surface of the tonometer head shall have a diameter of at least 6,0 mm and shall be
smooth to the touch. When examined by unmagnified corrected vision under direct illumination, the surface
shall be free from surface imperfections (free from fissures, cracks and dents) that could damage the eye.
Over a central area of not less than 4 mm diameter, the front surface shall be a plane structure with a “peak to
valley” deviation from a plane surface of less than 3,0 µm. The outer edge of this tonometer head shall be
smoothed. The front surface flatness requirement shall be verified using the method given in A.2.3.6 or an
alternate equivalent method.
A.1.4 Measuring force
The measuring force shall be continuously adjustable within a minimum range extending from 0 mN to
49,0 mN, without the use of auxiliary weights. The measured value of the force shall be clearly legible on a
linearly divided scale or a digital indication.
The change of force required to move the tonometer head in the opposite direction (reverse span) at the point
of transition shall not exceed 0,49 mN.
A.1.5 Display
If lines are used as graduations on the measuring scale, they shall be straight, of equal width, and shall be
engraved or otherwise permanently marked. No line shall be wider than 1/4 of the distance between two lines.
If a digital disp
...