1、February 2010 Translation by DIN-Sprachendienst.English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.040.70!$Nl“1574373www.din.deDDIN EN ISO 8612Ophthalmic instruments Tonometers (ISO 8612:2009)English translation of DIN EN ISO 8612:2010-02Ophthalmische Instrumente Augentonometer (ISO 8612:2009)Englische bersetzung von DIN EN ISO 8612:2010-02Instruments ophtalmiques Tonomtres (ISO 8612:2009)T
3、raduction anglaise de DIN EN ISO 8612:2010-02SupersedesDIN EN ISO 8612:2001-08www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 19 pages03.10 DIN EN ISO 8612:2010-02 2 A comma is used as the decimal marker. National foreword This standard
4、 has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in
5、 its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). The DIN Standards corresponding to the International Standards referred to in clause 2 of this document are as follows: ISO 15004-1 DIN EN ISO 15004-1 IEC 60601-1 DIN EN 60601-1 Amen
6、dments This standard differs from DIN EN ISO 8612:2001-08 as follows: a) It has been specified that tonometers meeting the requirements of Annex A for reference tonometers need not undergo design compliance testing according to Annex B. b) Information to be provided by the manufacturer for design co
7、mpliance testing has been reduced. c) Reference tonometer (Annex A): Requirements for the flatness of the tonometer head and the corresponding verification procedures have been specified. d) Design compliance testing (Annex B): For the selection of the subjects, central corneal thicknesses 0,600 mm
8、have been specified as exclusion criteria. e) Design compliance testing (Annex B): The minimum number of measurements has been changed from 150 eyes to 120 measurement pairs and details relating to repeated measurements have been specified. f) The text of ISO 8612:2009 has been adopted. Previous edi
9、tions DIN EN ISO 8612: 2001-08 National Annex NA (informative) Bibliography DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN 60601-1, Medical electrical equipment Part 1: General requirem
10、ents for basic safety and essential performance EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8612 October 2009 ICS 11.040.70 Supersedes EN ISO 8612:2001English Version Ophthalmic instruments - Tonometers (ISO 8612:2009) Instruments ophtalmiques - Tonomtres (ISO 8612:2009) Ophthalmische I
11、nstrumente - 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 altera
12、tion. 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 trans
13、lation 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, German
14、y, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG M
15、anagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8612:2009: EContents 2 DIN EN ISO 8612:2010-02 EN ISO 8612:2009 (E) Page Foreword .3 1 Scope4 2 Normative references4 3 Te
16、rms and definitions .4 4 Requirements.5 4.1 General .5 4.2 Design compliance testing (certification).5 4.3 Verification (instrument compliance)5 4.4 Construction and function6 5 Test methods .6 6 Accompanying documents 6 7 Additional information 6 8 Marking.7 Annex A (normative) Reference tonometer
17、and method for determining reference IOP8 Annex B (normative) Design compliance testing15 Foreword 3 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 nat
18、ional 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 supersed
19、es 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, Icel
20、and, 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. This
21、 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 DIN EN ISO 8612:2010-02 EN ISO 8612:2009 (E) 1 Scope This International Standard, together with IS
22、O 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 s
23、eldom 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 applicati
24、on 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 t
25、o 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 e
26、ye 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 A
27、nnex A, in accordance with the procedures given in Annex B 4 DIN EN ISO 8612:2010-02 EN ISO 8612:2009 (E) 3.5 measured IOP IOP reading provided by the test tonometer when used in accordance with the manufacturers instructions 4 Requirements 4.1 General 4.1.1 The test tonometer shall conform to the g
28、eneral 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
29、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
30、 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
31、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 mmHg Tolerance mmHg Minimum number of eyes 7 to16 5,0 40 16 to 16 mmHg to 23 mmHg 40 measurement pairs W 23 mmHg 4
32、0 measurement pairs In the W 23 mmHg group, repeat measurement pairs may be acquired from the same eye. In this group the maximum number of measurement pairs per eye acquired in this manner shall be six. Of the 40 measurement pairs in this group at least two eyes shall have reference tonometer intra
33、ocular pressures of 30 mmHg or higher. The time interval between each pair of repeated measurements shall be not less than 5 min. B.5.4 The monitor shall ensure that a rule for stopping recruitment of test subjects has been specified and recorded in advance of the test, and that it is not conditiona
34、l on the results obtained in the test. NOTE To aid selection, the subjects can be invited to participate on the basis of prior knowledge of their respective pressures or by preliminary pressure readings. B.5.5 One or both eyes of each subject shall be used. If the investigator chooses to measure onl
35、y one eye, the choice shall be made before any pressures are taken with the test tonometer. B.5.6 If, with any subject, it proves impossible to obtain all required readings with the reference tonometer or the test tonometer, the subject shall be withdrawn from the test. The investigators and the man
36、ufacturer shall report the number of subjects for whom measurements could not be made with each instrument and the reasons why. 16 DIN EN ISO 8612:2010-02 EN ISO 8612:2009 (E) B.6 Pressure readings B.6.1 The order of testing with the reference and test instruments shall be specified and selected to
37、minimize the effects of one measurement upon the next. The measurements with the test tonometer shall be as recommended by the manufacturer for routine use. B.6.2 All specified readings on each eye shall be taken without interruption over as short a time period as possible; that is, the time interva
38、l between two successive measurements shall not be longer than approximately three times the time for one test run. The test should be organized so that the subject has to move as little as possible. B.7 Withdrawal from the test B.7.1 The monitor shall ensure that the reasons for the withdrawal of a
39、ny investigator, tonometer or subject are recorded. B.7.2 If an investigator cannot complete the test, the monitor shall recruit a replacement. Measurements taken by the original investigator shall not be discarded. B.7.3 The monitor shall ensure that no investigators results can be influenced by th
40、e results of any prior reading. B.7.4 The sponsor shall make provision for replacing any of the test tonometers that are accidently damaged or which suffer a major fault that makes them unusable. B.7.5 If the calibration of the reference tonometer is found to be incorrect, all readings taken subsequ
41、ent to the last verification shall be discarded. B.8 Recording the data and test termination B.8.1 The monitor shall ensure that complete and accurate records are kept during the test. B.8.2 The monitor shall design a data collection means for use in the test. B.8.3 The monitor is responsible for te
42、rminating the test. B.8.4 The monitor may terminate the test if it becomes obvious that the tolerances will not be met. B.9 Data analysis B.9.1 The monitor shall be responsible for the analysis of the test data. B.9.2 When multiple measurements are made with the reference tonometer, the lowest measu
43、rement shall be used in the analysis. Where differences are greater than 5 mmHg, all measurements on this eye shall be excluded. B.9.3 For each measurement pair, a difference shall be calculated by subtracting the reference tonometer measurement from the test tonometer measurement. This difference s
44、hall be compared with the tolerance found in Table 1 for that pressure range. The applicable pressure range shall be determined by the pressure measurement of the reference tonometer. If the difference is outside the tolerance range, that measurement pair shall be counted in the subset which falls outside the tolerance. 17 DIN EN ISO 8612:2010-02 EN ISO 8612:2009 (E)
