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1、J IS JAPANESE I N DUSTRIAL STANDARD Translated and Published by Japanese Standards Association T 7309 : 2002 (JMOIA / JSA) Visual acuity testing equipment ICs 11.040.70 Reference number : JIS T 7309 : 2002 (E) PROTECTED BY COPYRIGHT 14 S Copyright Japanese Standards Association Provided by IHS under
2、 license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS -,-,- T 7309 : 2002 Foreword This translation has been made based on the original Japanese Industrial Standard revised by the
3、Minister of Health Labour and Welfare through deliberations at the Japanese Industrial Standards Committee, as the result of proposal for revision of Japanese Industrial Standard submitted by the Japan Medical-optical Equipment Industrial Association (JMOIA)/ the Japanese Standards Association (JSA)
4、 with the draft being attached, based on the provision of Article 12 Clause 1 of the Industrial Standard- ization Law applicable to the case of revision by the provision of Article 14. Consequently JIS T 7309 : 1988 is replaced with this Standard. This revision has been made based on IS0 8596 : 1994
5、 Ophthalmic optics- Visual acuity testing-Standard optotype and its presentation and IS0 8597 : 1994 Optics and optical instruments-Visual acuity testing-Method of correlating optotypes for the purposes of making it easier to compare this Standard with International Standards; to prepare Japanese In
6、dustrial Standard conforming with International Standards; and to propose a draft of an International Standard which is based on Japanese Industrial Standard. Date of Establishment: 1988-08-25 Date of Revision: 2002-08-01 Date of Public Notice in Official Gazette: 2002-08-01 Investigated by: Japanes
7、e Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS T 7309 : 2002, First English edition published in 2003-08 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as
8、to the contents, the original JIS is to be the final authority. O JSA 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in wri
9、ting from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS
10、 -,-,- Contents T 7309 : 2002 Page Introduction . 1 2 3 4 5 6 6.1 6.2 6.3 7 7.1 7.2 7.3 8 9 9.1 9.2 10 11 Scope Normative references Definitions Classification Environmental conditions Optotypes Optotypes Optotypes other than Landolt ring Dimensions of Landolt ring optotypes . Performance Standard v
11、isual acuity testing equipment Semi-standard visual acuity testing equipment Special visual acuity testing equipment . Construction, function and quality Tests . Test regarding safety Performance test Instruction manual Marking . Annex A (normative) Correlated test method between letters and graph o
12、ptotypes and Landolt ring Annex B (informative) Long distance visual acuity testing method and test report Annex 1 (informative) Comparison table between JIS and corresponding International Standards . 1 1 1 2 3 3 3 3 3 3 3 3 5 6 6 6 6 7 8 8 9 12 14 (i 1 PROTECTED BY COPYRIGHT Copyright Japanese Sta
13、ndards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 7309 : 2002 Visual acuity testing equipment I
14、ntroduction This Japanese Industrial Standard has been made adopting the cor- responding International Standard about the optotypes and their performance used for the standard visual acuity testing equipment classified as one of three types of visual acuity testing equipment specified in JIS T 7309
15、published in 1988 as the first edition on the basis of IS0 8596 Ophthalmic optics-Visual acuity testing- Standard optotype and its presentation published in 1994 as the first edition, and by modifying the presentation and/or technical contents of the standard. The specifica- tion not included in the
16、 original International Standard, namely, the specification for semi-standard visual acuity testing equipment and special visual acuity testing equipment and the specification concerning environmental conditions, tests and in- struction manual are added to this Japanese Industrial Standard. In addit
17、ion, by adopting IS0 8597 Optics and optical instruments-Visual acuity testing-Method of correlating optotypes published in 1994 as the first edition and by modifying the presentation and/or technical contents with respect to the correlating testing method between Landolt ring and letter, and graphi
18、c optotypes, Annex A (normative) has been prepared. The list in which the modification and addition to IS0 8596 and IS0 8597 are given, together with the explanation, is Annex 1 (informative). 1 Scope This Standard specifies the equipment used for testing visual acuity (here- after referred to as “v
19、isual acuity testing equipment”) and the optotypes for testing visual acuity (hereafter referred to as “optotypes”). Remarks 1 The chart projectors for testing visual acuity are specified in JIS T 7310. 2 The correlating test method between letters and graphic optotypes and Landolt rings is specifie
20、d in Annex A (normative). 3 Long distance visual acuity testing method and test report are supple- mented in Annex B (informative). 4 The International Standard corresponding to this Standard is as follows: In addition, symbols which denote the degree of correspondence in the contents between the re
21、levant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) ac- cording to ISO/IEC Guide 21. IS0 8596 : 1994 Ophthalmic optics-Visual acuity testing-Standard optotype and its presentation (MOD) IS0 8597 : 1994 Optics and optical instruments-Visual acuity test-
22、 ing-Method of correlating optotypes (MOD) 2 Normative references The following standards contain provisions which, through reference in this Standard, constitute provisions of this Standard. If the indication of the year of publication is given to these referred standards, only the edition of the P
23、ROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 7309 : 2002 indicated year const
24、itutes the provision of this Standard but the revision and amendment made thereafter do not apply. The normative references without the indication of the year of publication apply only to the most recent edition (including amendments 1. JIS B 7153 Measuring microscopes JIS 3 7184 Profile projectors
25、JIS C 7614 Methods of luminance measurements in lighting fields JIS T 0601-1 Medical electrical equipment-Part 1 : General requirements for safety Remarks : IEC 60601-1 : 1988 Medical electrical equipment-Part 1 : General re- quirements for safety, Amendment 1 : 1993 and Amendment 2 : 1995 are ident
26、ical with the said standard JIS Z 8120 IS0 3 : 1973 Glossary of optical terms Preferred numbers-Series of preferred numbers 3 Definitions 8120 and the following definitions apply. For the purposes of this Standard the definitions given in JIS Z standard visual acuity testing equipment: equipment man
27、ufactured for test- ing long distance visual acuity using the optotypes which consist of an eight- position Landolt ring and placing emphasis on the accuracy of the test. semi-standard visual acuity testing equipment: equipment manufactured for testing long distance visual acuity using the optotype
28、of Landolt rings and, partially, the optotypes of other type and placing emphasis on practical use, including those of reflecting use by mirror. special visual acuity testing equipment: equipment not included in the stan- dard visual acuity testing equipment and semi-standard visual acuity testing e
29、quipment, namely, short distance visual acuity testing equipment, individual letter visual acuity testing equipment, visual acuity testing equipment for screen- ing, visual acuity testing equipment for both eyes opened testing, optical visual acuity testing equipment, etc. short distance visual acui
30、ty test equipment: equipment for testing the visual acuity over a short distance mainly for the purpose of short distance work and, clinically, mainly for the purpose of the prescription for farsighted glasses. individual letter visual acuity testing equipment: visual acuity testing equipment which
31、presents the optotype one by one. visual acuity testing equipment for screening: visual acuity testing equip- ment for group medical examinations from a screening test at the primary stage to precise examination. visual acuity testing equipment for both eyes opened testing: visual acuity testing equ
32、ipment capable of testing the visual acuity of right and left eyes in- dividually and both eyes simultaneously where both eyes are opened. optical visual acuity testing equipment: of such construction that the optotypes are indicated by an optical system. visual acuity testing equipment PROTECTED BY
33、 COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 7309 : 2002 i) viewing distance: the optoty
34、pe. a distance between the entrance pupil of the subject and 4 Classification The visual acuity testing equipment shall be classified into the following three types: a) b) c) Standard visual acuity testing equipment Semi-standard visual acuity testing equipment Special visual acuity testing equipmen
35、t 5 Environmental conditions As specified in JIS T 0601-1. 6 Optotypes 6.1 Optotypes For the optotypes, the Landolt ring shown in Fig. 1, optotypes of a letter such as letter E, KATAKANA, HIRAGANA, numeral, other alphabet, let- ters, etc. and graphic optotypes such as shadow pictures, line drawings,
36、 etc. shall be used. Out of all of these, the Landolt ring is used as the standard optotype. Outsidediameter I - Ring width u Gap width Fig. 1 Landolt ring 6.2 Dimensions of Landolt ring optotypes The dimensions of the Landolt ring is that, for the visual acuity 1.0, the visual angle is 5 in externa
37、l form and 1 in ring width and gap width and for the visual acuity a, lla of the optotypes for the visual acuity 1.0. 6.3 Optotypes other than Landolt ring The optotypes other than the Landolt ring are correlated clinic-experimentally with the Landolt ring so as to be the optotypes whose drawing met
38、hod and standard value of dimensions are classified. The corre- lated testing method between the Landolt ring and other letter and graphic optotypes should preferably be in accordance with Annex A (normative). 7 Performance 7.1 Standard visual acuity testing equipment The performance of the stan- da
39、rd visual acuity testing equipment shall be as follows: PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without li
40、cense from IHS -,-,- 4 T 7309 : 2002 7.1.1 Optotypes to be used Eight-position Landolt ring is used. 7.1.2 Visual acuity and visual acuity grade The visual acuity is expressed with the reciprocal of the visual angle (unit in minute) of the gap width and the grade of visual acuity is as given in Tabl
41、e 1. a) The optotypes are in an arrangement of arithmetical series in the logarithmic expression and in an arrangement of geometric series in the visual angle. The quotient of the visual angle of a test type divided by the next smaller one is the series of preferred numbers R10 from IS0 3. % f = 1.2
42、58 9 b) Optotypes of acuity grades 0.05, 0.063, 0.08, 2.0 may be omitted if necessary. Addition of further acuity grades is permitted. Table 1 Visual acuity grades Acuity grade 0.05 0.063 (0.06) (2) 0.08 0.1 0.125 0.16 0.2 0.25 0.32 (0.3) 0.4 0.5 0.63 (0.6) (2) (0.71 0.8 1.0 1.25 1.6 2.0 Log gap siz
43、e +1.3 +1.2 +1.1 +1.0 +0.9 +0.8 +0.7 +0.6 +0.5 +0.4 +0.3 +0.2 +0.151 (l) +0.1 0.0 -0.1 -0.2 Optotype size: gap width and ring width Visual angle () 20 16 12.5 10 8 6.3 5 4 3.2 2.5 2 1.6 ( 1 . 4 1 (9 1.25 1 0.8 0.63 Permissible deviation % I 5 -0.3 I 0.5 I f 10 Minimum number of optotypes at the same
44、 grade 2 3 5 Notes (1) 0.7 in Table 1 which is not in accordance with the arrangement of optotypes shows that the addition of the visual acuity 0.7 is prefer- able from the view point of domestic law. (2) The numerical values given in ( ) in the Table 1 are used only for identifying the visual acuit
45、y grade. 7.1.3 Accuracy of optotypes The accuracy of optotypes is I 5 % of the standard value up to the visual acuity 1.6 and f 10 % of the standard value at the visual acuity 2.0, when tested in accordance with the method specified in 9.2.1. PROTECTED BY COPYRIGHT Copyright Japanese Standards Assoc
46、iation Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 19:17:08 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 7309 : 2002 Acuity grade 7.1.4 Minimum number of optotypes at the same grade As given in
47、 Table 1. Minimum spacing between standard optotypes 7.1.5 Test area The field extends at least 0.5“ in all directions from the contour of the optotypes to the border of the test field. 0.05 or less 0.06 to 0.125 0.16 to 0.32 7.1.6 Spacing between optotypes If more than one acuity grade is used on t
48、he test area, the spacing is as given in Table 2. Twice the gap width of Landolt Diameter of Landolt ring 1.5 times the diameter of Landolt ring 0.4 to 1.0 Greater than 1.0 Twice the diameter Landolt ring 3 times the diameter of Landolt ring - Remarks : Table 2 applies to both horizontal and ver- tical spacing. 7.1.7 Luminance The luminance conforms, when tested in accordance with the method specified in 9.2.2, to the following requirements: a) The luminance in the test area is 80 cd/m2 to 320 cd/mz (recommended lumi- nance is 200 cd/m2). b) The luminance of