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1、AMERICAN NATIONAL STANDARDAMERICAN NATIONAL STANDARD OLA for Ophthalmics Devices for Low Vision ANSI Z80.9-2004 ANSI Z80.9-2004 Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:
2、50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted
3、 without license from IHS -,-,- ANSI Z80.9-2004 Revision of ANSI Z80.9-1998 American National Standard for Ophthalmics Devices for Low Vision Secretariat Optical Laboratories Association Approved January 10, 2005 American National Standards Institute, Inc. Copyright American National Standards Insti
4、tute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- Approval of an American National Standard requires review by ANSI that the requirements for
5、 due process, consensus, and other criteria for approval have been met by the standards developer. Consensus is established when, in the judgement of the ANSI Board of Standards Review, substantial agreement has been reached by directly and materially affected interests. Substantial agreement means
6、much more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that a concerted effort be made towards their resolution. The use of American National Standards is completely voluntary; their existence does not in any respect precl
7、ude anyone, whether he has approved the standards or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standards. The American National Standards Institute does not develop standards and will in no circumstances give an interpretation o
8、f any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation of an American National Standard in the name of the American National Standards Institute. Requests for interpretations should be addressed to the secretariat or sponsor whose name appe
9、ars on the title page of this standard. CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken periodically to reaffirm, revise, or withdraw this standard. Purchasers of America
10、n National Standards may receive current information on all standards by calling or writing the American National Standards Institute. American National Standard Published by Optical Laboratories Association P. O. Box 2000 Merrifield, VA 22116-2000 Copyright 2005 by Optical Laboratories Association
11、All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the United States of America Developed by The Accredited Committee Z80 for Ophthalmic Standards - Optical Labo
12、ratories Association Z80 Secretariat P. O. Box 2000 Merrifield, VA 22116-2000 Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted w
13、ithout license from IHS -,-,- i Contents Page Foreword .iii 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 Classification 5 5 Requirements. 5 5.1 Optical devices. 5 5.1.1 Spatial resolution . 5 5.1.2 Equivalent power - magnifiers 5 5.1.3 Angular Magnification - telescopes 5 5.1.4
14、Field of view. 6 5.1.5 Lateral variation of magnification. 6 5.1.6 Transmittance 6 5.1.7 Materials and construction. 6 5.2 Electro-optical devices. 7 5.2.1 Image characteristics. 7 5.2.2 Materials and construction. 8 5.2.3 Electrical 8 6 Environmental conditions of use 9 7 Test methods. 9 7.1 Equiva
15、lent power - Magnifiers 9 7.2 Angular magnification - Telescopes. 9 7.3 Display magnification test - electro-optical devices . 9 7.4 Spatial resolution test. 10 7.4.1 Optical devices. 10 7.4.2 Electro-optical devices. 13 7.5Test for the determination of lateral variation of magnification 13 7.6Field
16、 of view. 13 8 Marking, packaging and instructions for use 14 Tables 1Magnifiers/Near telescopes . 6 2Distance telescopes. 6 3Environmental conditions of use 9 Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/996103110
17、0 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ii Page Figures 1Example for an optotype with Ronchi rulings. 10 2Example for a test set-up for near-vision devices 11 3Example for a test set-up for telescopic systems 12 Annex AMechanica
18、l design. 15 Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- iii Foreword (This foreword is not
19、part of American National Standard ANSI Z80.9-2004.) The Z80 Standards Committee for Ophthalmic Lenses was organized in 1956. The Committees initial standard was issued in 1964. At the beginning of 1970, the Z80 Standards Committee was reorganized, with the Optical Society of America serving as secr
20、etariat. In 1972, the Committee was authorized to broaden its scope from “prescription glass ophthalmic lenses“ to “prescription ophthalmic lenses.“ In 1975, the scope of the committee was further broadened to “ophthalmic standards.“ On May 21, 1985, the Z80 Committee became the Accredited Standards
21、 Committee on Ophthalmic Standards with the Optical Laboratories Association serving as secretari- at. Current ophthalmic standards are drafted by subcommittees of the Z80 Commit- tee. These subcommittees, in turn, establish working groups and consultant appointments, In 1998, the Z80 Committee appr
22、oved adoption of ISO 15253, Optical Devices for Low Vision, as ANSI Z80.9-1998. In 2004, upon review of ANSI Z80.9-1998, the Z80 Committee further approved inclusion of ISO 15254, Electro-Optical Devices for Low Vision, into the revision of ANSI Z80.9, thus creating a single standard that includes a
23、ll classes of devices for Low Vision. Suggestions for improvement of this standard will be welcome. They should be sent to the Optical Laboratories Association, P.O. Box 2000, Merrifield, VA 22116-2000. This standard was processed and approved for submittal to ANSI by the Accredited Standards Commit
24、tee on Ophthalmics, Z80. Committee approval of this standard does not necessarily imply that all committee members voted for its approval. At the time it approved this standard, the Z80 Committee had the following members: Thomas C. White, M.D., Chair Quido Cappelli, Vice-Chair Robert Rosenberg, O.D
25、., Secretary Dan Torgersen, Secretariat Organization Represented Name of Representative AR CouncilNick Mileti Lee K. Anderson (Alt.) John W. Quinn (Alt.) Advance Medical Technologies Association .Douglas J. Fortunato Carolyn Jones (Alt.) Glenn Davies (Alt.) Stanley J. Rogaski (Alt.) American Academy
26、 of Optometry.David S. Loshin American Academy of Ophthalmology .Thomas C. White Gerhard Cibis (Alt.) Keith Baratz (Alt.) Paul F.Vinger (Alt.) American Optometric Association .Donald Pitts William J. Benjamin (Alt.) Robert Rosenberg (Alt.) Jeffrey Weaver (Alt.) American Society of Cataract and Refra
27、ctive Surgery .Stephen Klyce, Ph.D. Jack T. Holladay (Alt.) Stephen H. Johnson (Alt.) Contact Lens Institute.Ed Schilling Contact Lens Manufacturers Association.Quido Cappelli Food Avert = linear expansion of field of view in vertical direction, measured in mm. The procedure is subsequently repeated
28、, with the optotype only being moved to the edge of the low-vision device until one of the directions of the Ronchi ruling cannot be identified. Here once again, the measured values are read off the scale, therefore providing the horizontal and vertical expansion of the still resolvable field of vie
29、w. The observation telescope shall not be refocused during this procedure. The following values are obtained: Ahor* = linear expansion of resolvable field of view in horizontal direction (mm); Avert* = linear expansion of resolvable field of view in vertical direction (mm) Instead of performing the
30、test in the vertical direction, where difficulties can be experienced when measuring the expansion, it is possible to turn the low-vision device about 90. Figure 3 Example of a test set-up for telescopic systems Copyright American National Standards Institute Provided by IHS under license with ANSI
31、Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI Z80.9-2004 13 7.4.1.5.2 For telescopes After exact alignment of the test set-up, the field of view attainable with the respective l
32、ow-vision device is determined. Here, the optotype is moved to the frame edge of the low-vision device in order to establish to what extent the optotype is visible. This is performed horizontally and vertically. The horizontal and vertical expansion of the field of view is determined by reading the
33、respective measured values off the scale. Two values are obtained: Ahor = linear expansion of field of view in horizontal direction, measured in mm; Avert = linear expansion of field of view in vertical direction, measured in mm. This procedure is subsequently repeated, with the optotype only being
34、moved to the edge of the low-vision device until one of the directions can no longer be allocated to the Ronchi ruling. Here once again, the measured values are read off the scale, providing the horizontal and vertical expansion of the still resolvable field of view. The following values are obtaine
35、d: Ahor * = linear expansion of resolvable field of view in horizontal direction (mm); Avert* = linear expansion of resolvable field of view in vertical direction (mm). Instead of performing the test in the vertical direction, where difficulties can be experienced when measuring the expansion, it is
36、 possible to turn the low-vision device about 90. 7.4.1.5.3 Test evaluation For the evaluation, the formula (A* x 100) / A is used to obtain the percentage of the linear field of view at which the optotype can be resolved. 7.4.2 Electro-optical devices The test optotype is placed on the object table
37、 or in the otherwise located object position as instructed by the manufacturer, and the test procedure is carried out as in 7.4.1.5.1 except that the image may be evaluated by direct observation. 7.5 Test for the determination of lateral variation of magnification Magnification is measured as in cla
38、uses 7.1, 7.2, or 7.3 (as appropriate for the device) across the field vertically and horizontally. 7.6 Field of view At the magnification specified by the manufacturer, the optotype is moved toward the edge of the observed field until one of the directions of the Ronchi ruling cannot be identified
39、and a scale measurement is taken. The values read off the scale provide the horizontal and vertical field measurement. Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDT
40、No reproduction or networking permitted without license from IHS -,-,- ANSI Z80.9-2004 14 8 Marking, packaging and instructions for use 8.1 Marking Each device shall be clearly marked with at least the following: a) An identification of the device and the manufacturer with model and serial number (w
41、here applicable). b) Where a device is not designed as a complete system, the manufacturer shall state the types of display that are compatible and suitable to meet the requirements of this standard and their minimum specifications. The manufacturer shall also state the recommended display size for
42、which the range of magnification applies. c) Where the device is designed as a complete system, the manufacturer shall state the free working distance at maximum display magnification. d) The manufacturers declared value for the equivalent power for magnifiers. e) The manufacturers declared value fo
43、r angular magnification for telescopes. f) The manufacturers stated range of magnification (where applicable). g) The manufacturers declared value for either nominal magnification or equivalent power for telemicro- scopes/near-vision telescopes. h) The manufacturers declared value for the field of v
44、iew. For devices of variable magnification, field of view at maximum and minimum magnifications with a stationary object (target) shall be declared. i) Additional markings as required by UL 60601-1. j) For cathode ray tube (CRT) displays, refresh rate 8.2 Documentation 8.2.1 A manual shall be provid
45、ed giving user instructions in large print. 8.2.2 Instructions for care and maintenance of the device in large print shall be provided. Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/
46、2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI Z80.9-2004 15 Annex A (informative) Mechanical design All controls, knobs, buttons or switches shall be made easy to distinguish by the use of suitably contrasting colors, and of sufficient size that they are useable by the visually impaired. Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 22:50:43 MDTNo reproduction or networking permitted without license from IHS -,-,-