SIST EN ISO 8612:2002
(Main)Ophthalmic instruments - Tonometers (ISO 8612:2001)
Ophthalmic instruments - Tonometers (ISO 8612:2001)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
Ophthalmische Instrumente - Tonometer (ISO 8612:2001)
Diese Internationale Norm legt zusammen mit ISO 15004 Mindestanforderungen und das Anschlußverfahren für Tonometer fest, die zum routinemäßigen praktischen Gebrauch bei der Beurteilung des intraokularen Druckes (IOP) dienen sollen. Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004. Anmerkung 1: Der wahre intraokulare Druck wird selten direkt gemessen, da dies invasiv erfolgen müßte. Da der wahre intraokulare Druck nicht bekannt sein kann, werden hier Instrument (Anhang A) und Verfahren (Anhang B) zur Bestimmung eines Referenzdruckes angegeben.
Instruments ophtalmiques - Tonometres (ISO 8612:2001)
Očesni instrumenti – Tonometri (ISO 8612:2001)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8612:2002
01-maj-2002
2þHVQLLQVWUXPHQWL±7RQRPHWUL ,62
Ophthalmic instruments - Tonometers (ISO 8612:2001)
Ophthalmische Instrumente - Tonometer (ISO 8612:2001)
Instruments ophtalmiques - Tonometres (ISO 8612:2001)
Ta slovenski standard je istoveten z: EN ISO 8612:2001
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 8612:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8612:2002
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SIST EN ISO 8612:2002
EUROPEAN STANDARD
EN ISO 8612
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2001
ICS 11.040.70
English version
Ophthalmic instruments - Tonometers (ISO 8612:2001)
Instruments ophtalmiques - Tonomètres (ISO 8612:2001) Ophthalmische Instrumente - Tonometer (ISO 8612:2001)
This European Standard was approved by CEN on 15 April 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8612:2001 E
worldwide for CEN national Members.
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SIST EN ISO 8612:2002
Page 2
EN ISO 8612:2001
Foreword
The text of the International Standard ISO 8612:2001 has been prepared by Technical
Committee ISO/TC 172 "Optics and optical instruments" 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 October 2001, and conflicting national
standards shall be withdrawn at the latest by October 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,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 8612:2001 was approved by CEN as a European
Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).
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SIST EN ISO 8612:2002
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EN ISO 8612:2001
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 15004 1997 Ophthalmic instruments - Fundamental EN ISO 15004 1997
requirements and test methods
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SIST EN ISO 8612:2002
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SIST EN ISO 8612:2002
INTERNATIONAL ISO
STANDARD 8612
First edition
2001-04-15
Ophthalmic instruments — Tonometers
Instruments ophtalmiques — Tonomètres
Reference number
ISO 8612:2001(E)
©
ISO 2001
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SIST EN ISO 8612:2002
ISO 8612:2001(E)
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ii © ISO 2001 – All rights reserved
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SIST EN ISO 8612:2002
ISO 8612:2001(E)
Contents Page
Foreword.iv
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
5 Test methods.3
6 Accompanying documents.3
7 Additional information .4
8 Marking .4
Annex A (normative) Reference tonometer and method for determining reference IOP .5
Annex B (normative) Design compliance testing .11
© ISO 2001 – All rights reserved iii
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SIST EN ISO 8612:2002
ISO 8612:2001(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 8612 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
This first edition of ISO 8612 cancels and replaces ISO/TR 8612:1997, which has been technically revised.
Annexes A and B form a normative part of this International Standard.
iv © ISO 2001 – All rights reserved
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SIST EN ISO 8612:2002
INTERNATIONAL STANDARD ISO 8612:2001(E)
Ophthalmic instruments — Tonometers
1 Scope
This International Standard, together with ISO 15004, 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 the ISO 15004, if differences exist.
NOTE 1 The true intraocular pressure is seldom directly measured since it would require invasion of the eye. Since the true
IOP cannot be known, the instrument (annex A) and method (annex B) for determining a reference IOP are instead specified.
NOTE 2 Clinical tonometers may employ different parameters or correlates in the indirect assessment of measured IOP. The
manufacturer states the exact design parameters of the specific tonometer, and then, on the basis of design compliance testing
as specified in 4.2, demonstrates that the specific design performs acceptably compared to the reference method. This process
is referred to as certification.
The manufacturer also demonstrates, by methods specified in 4.3, that individual manufactured instruments perform the same
(within defined limits) as the test tonometer. This process is referred to as verification.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 15004, Ophthalmic instruments — Fundamental requirements and test methods.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
3 Terms and definitions
For the purposes of this International Standard, 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 = 1,333 hPa.
3.2
reference IOP
IOP that is measured with a reference tonometer, as specified in annex A, in accordance with the procedures given
in annex B
© ISO 2001 – All rights reserved 1
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SIST EN ISO 8612:2002
ISO 8612:2001(E)
3.3
measured IOP
IOP reading provided by the tonometer when used in accordance with the manufacturer’s instructions
3.4
reference tonometer
tonometer as described in annex A
3.5
test tonometer
verified tonometer used in design compliance testing
4 Requirements
4.1 General
The tonometer shall conform to the general requirements specified in ISO 15004.
The 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.
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 the unavoidable error associated with the
reference tonometer.
Table 1 — Requirements for tonometers
IOP range Tolerance
Minimum number of eyes
mmHg mmHg
7to16 � 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 7 a), 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 that were used to measure and verify the test tonometer in 4.2.
Details of the method and test apparatus shall be made available in accordance with the requirements of clause 7.
2 © ISO 2001 – All rights reserved
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SIST EN ISO 8612:2002
ISO 8612:2001(E)
4.3.2 The permissible error of the test apparatus shall be one-half of the permissible tolerance as given in
Table 1.
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) smooth when felt with the finger, and be free of surface imperfections that would damage the eye or prevent
adequate disinfection, when examined by unmagnified corrected vision under specular reflection.
4.4.2 The tonometer shall permit the measurement of IOP throughout the range 7 to 50. 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 IOPs less than 7 shall be displayed either by their numerical value or by a "low reading" indication.
Readings of IOPs greater than 50 shall be displayed either by their numerical value or by a "high reading"
indication.
5 Test methods
5.1 All tests described in this International Standard are type tests.
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, with particular reference to the
disinfection of instruments to be returned to the manufacturer for repair and maintenance;
c) any contra-indications for the use of the tonometer;
d) a list of accessories suitable for use with the tonometer;
e) if appropriate, a statement that the tonometer in its original packaging conforms to the transport conditions as
specified in ISO 15004;
f) if appropriate, any additional documents as specified in 6.8 of IEC 60601-1:1988;
g) a reference to this International Standard, i.e. ISO 8612, if the manufacturer or supplier claims compliance
with it.
© ISO 2001 – All rights reserved 3
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SIST EN ISO 8612:2002
ISO 8612:2001(E)
7 Additional information
The manufacturer shall provide the following information upon request:
a) information on the operating principles of the certified tonometer, specific protocol for design compliance
testing (annex B), specific results of design compliance testing with statistical evaluation;
b) documentation describing the verification test apparatus, verification procedures and its own verification test
results for that tonometer;
c) a full specification for the apparatus required for verification, sufficient to allow the purchaser or purchaser's
representative to construct or acquire such test apparatus.
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 8612:2002
ISO 8612:2001(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-op
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