ANSI Z80.10-2014 Ophthalmics Ophthalmic Instruments C Tonometers (VC)《眼科仪器.眼压计》.pdf

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1、American National Standardfor OphthalmicsOphthalmic Instruments TonometersANSI Z80.10-2014ANSIZ80.10-2014ANSIZ80.10-2014Revision ofANSI Z80.10-2009American National Standardfor Ophthalmics Ophthalmic Instruments TonometersSecretariatThe Vision CouncilApproved December 5, 2014American National Standa

2、rds Institute, Inc.Approval of an American National Standard requires review by ANSI that therequirements for due process, consensus, and other criteria for approval havebeen met by the standards developer.Consensus is established when, in the judgement of the ANSI Board ofStandards Review, substant

3、ial agreement has been reached by directly andmaterially affected interests. Substantial agreement means much more thana simple majority, but not necessarily unanimity. Consensus requires that allviews and objections be considered, and that a concerted effort be madetowards their resolution.The use

4、of American National Standards is completely voluntary; theirexistence does not in any respect preclude anyone, whether he has approvedthe standards or not, from manufacturing, marketing, purchasing, or usingproducts, processes, or procedures not conforming to the standards.The American National Sta

5、ndards Institute does not develop standards andwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational Standards Institute. R

6、equests for interpretations should beaddressed to the secretariat or sponsor whose name appears on the titlepage of this standard.CAUTION NOTICE: This American National Standard may be revised orwithdrawn at any time. The procedures of the American National StandardsInstitute require that action be

7、taken periodically to reaffirm, revise, orwithdraw this standard. Purchasers of American National Standards mayreceive current information on all standards by calling or writing the AmericanNational Standards Institute.American National StandardPublished byThe Vision Council225 Reinekers Lane, Suite

8、 700Alexandria, VA 22314Copyright 2015 by The Vision CouncilAll rights reserved.No part of this publication may be reproduced in anyform, in an electronic retrieval system or otherwise,without prior written permission of the publisher.Printed in the United States of AmericaDeveloped byThe Accredited

9、 Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers Lane, Suite 700Alexandria, VA 22314iContentsPageForeword .i1 Scope . 12 Normative references . 13 Definitions. 24 Requirements . 25 Test methods 36 Accompanying documents . 47 Additional information. 48 Marking.

10、5Tables1 Requirements for paired testing of reference to test tonometers . 2AnnexesA The reference tonometer and method for determining reference IOP 6B Design compliance testing 13C Example of a test certificate . 17iiForeword (This foreword is not part of American National Standard ANSI Z80.10-201

11、4.)This American National Standard covers tonometers specifically intended for routineclinical use in the estimation of intraocular pressure for the detection, diagnosis, andmanagement of ocular abnormalities and excludes uses such as monitoring inducedhigh intraocular pressure for refractive surger

12、y.ANSI Z80.10-2014 was adapted by a group of experts within the ANSI OphthalmicInstruments Subcommittee under the chair of William L. Brown, O.D., Ph.D. It is aperformance standard.This standard defines the tolerable range of intraocular pressure (IOP) readings incomparison to measurements made by a

13、 reference applanation tonometer such asthe Goldmann Tonometer. Normative references have been updated. Allowance ismade in this standard for a Goldmann-equivalent measurement, taken with an instru-ment that meets requirements for a test tonometer when compared to the Goldmannreference tonometer. Su

14、ch an instrument may present intraocular pressure data informats other than Goldmann. This standard clarifies that a new tonometer thatmeets all of the specifications and requirements of annex A is qualified as a refer-ence tonometer, and, therefore, it does not require the clinical validation descr

15、ibed inannex B and clause 4.2.1. Added to annex B is clause B.9.3, which modifies require-ments for statistical analysis. Allowance for multiple measurements with the refer-ence tonometer during testing with the test tonometer is disallowed in this standardwith the deletion of clause B.9.2Annexes A

16、and B are normative and are considered part of the standard. Annex C isinformative and is not considered part of the standard.Suggestions for improvement of this standard will be welcome. They should be sentto the Vision Council, 225 Reinekers Lane, Suite 700, Alexandria, VA 22314.This standard was

17、processed and approved for submittal to ANSI by the AccreditedStandards Committee on Ophthalmic Optics, Z80. Committee approval of this stan-dard does not necessarily imply that all committee members voted for its approval. Atthe time of approval of this standard, the Z80 Committee consisted of the

18、followingmembers:Thomas White, M.D., ChairmanQuido Cappelli, Vice-ChairmanWilliam Benjamin, O.D., SecretaryJeff Endres, SecretariatiiiOrganization Represented Name of RepresentativeAdvance Medical Technologies Association .Michael PflegerAmerican Academy of OphthalmologyDr. Thomas WhiteAmerican Acad

19、emy of Optometry .Dr. David LoshinAmerican Ceramic SocietyLyle RubinAmerican Glaucoma Society.Dr. Steven GeddeAmerican Optometric Association .Dr. Karl CitekAmerican Society of Cataract and Refractive Ophthalmology Dr. Stephen KlyceContact Lens Institute .Stan RogaskiContact Lens Manufacturers Assoc

20、iationQuido CappelliDepartment of Veterans Affairs.Dr. John TownsendFederated Cornea Societies/ASCRS Dr. Michael BelinFood & Drug Administration Don CalogeroNational Association of Optometrists & Opticians.Nick MiletiOptical Laboratory Association .Michael VitaleOpticians Association of AmericaTom H

21、icksSunglass Association of AmericaFrederick GrethelThe Vision Council Jeffrey EndresU.S. TAG Leader to ISO TC 172/SC7.Jeffrey EndresThe members of the subcommittee on Ophthalmic Instruments who contributed tothis standard are:William L. Brown, O.D., Ph.D, ChairCharles E. CampbellBruce DrumDavid Luc

22、eRobert RosenbergivAMERICAN NATIONAL STANDARD ANSI Z80.10-2014American National Standard for Ophthalmics Ophthalmic Instruments Tonometers 1 1 Scope This standard, together with ISO 15004-1:2009, Fundamental requirements and test methods Part 1: General requirements applicable to all instruments Fir

23、st edition, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP) for the detection, diagnosis, and management of ocular abnormalities. NOTES 1) The true intraocular pressure is seldom direc

24、tly 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 established. 2) Clinical tonometers may employ different parameters or correlates in the indirect assessment of measured IOP.

25、 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 manuf

26、acturer also demonstrates, by methods specified in 4.3, that individual manufactured instruments perform the same as (within defined limits) the test tonometer. This process is referred to as verification. 2 Normative references The following standards contain provisions which, through reference in

27、this text, constitute provisions of this Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standard

28、s listed below. Members of IEC and ISO maintain registers of currently valid standards. ISO 15004-1:2009, Fundamental requirements and test methods Part 1: General requirements applicable to all instruments First edition IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for

29、 basic safety and essential performance Third edition ANSI Z80.10-2014 2 3 Definitions For the purpose of this standard, the following definitions apply. 3.1 intraocular pressure (IOP): The pressure within the eye in millimeters of mercury (mmHg). NOTE - 1 mmHg = 1.333 hPa 3.2 reference IOP: The IOP

30、 that is measured with the reference tonometer (annex A) in accordance with the procedures given in annex B. 3.3 measured IOP: The IOP reading provided by the instrument when used in accordance with the manufacturers instructions. 3.4 reference tonometer: A tonometer as described in annex A. 3.5 tes

31、t tonometer: The verified tonometer used in design compliance testing. 3.6 Goldmann-equivalent measurement: An intraocular pressure measurement taken with an instrument that meets the requirements of 4.2 to 4.4 when compared to the Goldmann reference tonometer. The instrument may also present intrao

32、cular pressure data in other formats. 4 Requirements 4.1 General The tonometer shall conform to the requirements specified in ISO 15004:1:2006. The tonometer shall conform to the specific requirements specified in 4.2 to 4.4 for measured values designated as Goldmann-equivalent. This standard does n

33、ot prevent presentation of additional parameters or interpretations of the data that differ from Goldmann-equivalent measurements. However, if compliance with this standard is claimed, a tonometer shall make Goldmann-equivalent values available to the user and shall designate them as measurements co

34、nforming to ANSI Z80.10. 4.2 Type 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 compared to the reference tonometer measurements meet the requirement as given in table 1. Tabl

35、e 1 Requirements for paired testing of reference to test tonometers IOP range (mmHg) Tolerance of paired differences (mmHg) Minimum number of eyes 7 to 16 5 40 16 to 16 to 23 mmHg 40 eyes In addition to the 120 eyes, at least 10 highly astigmatic eyes (3 D of corneal astigmatism) each in the low, me

36、dium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group. In the 23 mmHg group, repeat measurement pairs may be acquired from the same eye. The time interval between each pair of repeated measurements shall be

37、not less than 5 min. In this group, the maximum number of measurement pairs per eye acquired in this manner shall be 6. Of the 40 measurement pairs in this group, at least 2 eyes shall have reference tonometer intraocular pressures of 30 mmHg or higher. B.5.4 The monitor shall ensure that a rule for

38、 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 may be invited to participate on the basis of prior knowledge of their pressures or by preliminary pre

39、ssure 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 test tonometer. ANSI Z80.10-2014 15 B.5.6 If, with any subject, it proves impossible to obtain all required read

40、ings 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 be made with each instrument and the reasons why. B.5.7 A subject shall not be used more t

41、han once. B.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 measurements with the test tonometer shall be as recommended by the manufacturer for routine use. B.6.2 Bef

42、ore completion of the clinical study, the monitor shall be responsible for defining an environment-specific protocol that (a) assures the integrity of each measurements reading, (b) assures the accuracy of recording, and (c) precludes the exchange of comparative matched pair measures (test vs. refer

43、ence). B.6.3 The test should be organized so that the subject has to move as little as possible. B.6.4 If an interruption occurs between or within readings, the whole procedure on that subject shall be restarted or excluded. B.7 Withdrawal from the test B.7.1 The monitor shall ensure that the reason

44、s for the withdrawal of any 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 investigator is remo

45、ved from the test for reasons related to the accuracy of their results. B.7.4 The sponsor shall make provision for replacing any of the test tonometers that are accidentally damaged or that suffer a major fault that makes them unusable. B.7.5 If the calibration of the reference tonometer is found to

46、 be incorrect, all readings taken subsequent 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

47、. B.8.3 The monitor is responsible for terminating the test. B.8.4 The monitor may terminate the test if it becomes obvious that the tolerances will not be met. ANSI Z80.10-2014 16 B.9 Data Analysis B.9.1 The monitor shall be responsible for the analysis of the test data. B.9.2 For each eye tested,

48、a difference shall be formed by subtracting the (mean) reference tonometer measurement from the test tonometer measurement. This difference shall be compared with the tolerance found in table 1 for that pressure range. The applicable pressure range shall be determined by the (mean) pressure measurem

49、ent of the reference tonometer. If the difference is outside the tolerance range, that eye shall be counted in the subset that falls outside the tolerance. B.9.3 The clinical agreement results, including the following presentation of results and analyses, shall be recorded and made available in accordance with clause 7(a). a) A scatter plot of the test tonometer measurements (x-axis) versus the reference tonometer measurements (y-axis, scaled identically to x-axis) with the total least squares fitting line and the y=x diagonal line drawn on the plot. b) Resu