EN ISO 8612-2009 en Ophthalmic instruments - Tonometers《眼科仪器 眼压计》.pdf

1、BS EN ISO8612:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Tonometers (ISO8612:2009)This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978

2、0 580 60809 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 8612:2009National forewordThis British Standard is the UK implementation of EN ISO 8612:2009. Itsupersedes BS EN ISO 8612:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommit

3、tee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British St

4、andard cannot confer immunityfrom legal obligations.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) Ophthalmisc

5、he 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 al

6、teration. 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 t

7、ranslation 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, Ge

8、rmany, 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 NORMU

9、NG Management 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: EBS EN ISO 8612:2009EN ISO 8612:2009 (E) 3 Foreword This document (EN ISO 8612:2009) has been prepared by T

10、echnical 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

11、, 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

12、 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, Estoni

13、a, 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

14、 a EN ISO 8612:2009 without any modification. BS EN ISO 8612:2009ISO 8612:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Requirements.2 4.1 General .2 4.2 Design compliance testing (certification).2 4.3 Verification (in

15、strument compliance) 2 4.4 Construction and function3 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 IOP5 Annex B (normative) Design compliance testing12 BS EN ISO 8612:2009ISO 8612:2009

16、(E) iv ISO 2009 All rights reservedForeword 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 in

17、terested 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 Electrotechni

18、cal 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

19、 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.

20、 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

21、 been technically revised. BS EN ISO 8612:2009INTERNATIONAL STANDARD ISO 8612:2009(E) ISO 2009 All rights reserved 1Ophthalmic instruments Tonometers 1 Scope This International Standard, together with ISO 15004-1, specifies minimum requirements and the design compliance procedure for tonometers inte

22、nded 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

23、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

24、, 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 requi

25、rements 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 referen

26、ce 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 BS EN ISO 8612:2009ISO 8612:2009(E) 2

27、ISO 2009 All rights reserved3.5 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 general requirements specified in ISO 15004-1. 4.1.2 The test tonometer shall c

28、onform 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 meas

29、urements, 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 t

30、onometer 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 al

31、so 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 40 measurement pairs In the W 23 mmHg group, repeat measurement pairs may be ac

32、quired 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 intraocular pressures of 30 mmHg or higher. The time interval between each pair of

33、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 conditional on the results obtained in the test. NOTE To aid selection, the subjects can

34、 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 only one eye, the choice shall be made before any pressures are taken with the te

35、st 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 manufacturer shall report the number of subjects for whom measurements could not

36、be made with each instrument and the reasons why. BS EN ISO 8612:2009ISO 8612:2009(E) 14 ISO 2009 All rights reservedB.6 Pressure readings B.6.1 The order of testing with the reference and test instruments shall be specified and selected to minimize the effects of one measurement upon the next. The

37、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 interval between two successive measurements shall not be longer t

38、han 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 any investigator, tonometer or subject are recorded. B.7.2 I

39、f 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 the results of any prior reading. B.7.4 The sponsor shall mak

40、e 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 subsequent to the last verification shall be discarded. B.8 Record

41、ing 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 terminating the test. B.8.4 The monitor may terminate the tes

42、t 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 measurement shall be used in the analysis. Where differences are

43、 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 shall be compared with the tolerance found in Table 1 for th

44、at 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. BS EN ISO 8612:2009BS EN ISO8612:2009

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