ANSI Z80.9-2010 Ophthalmics C Devices for Low Vision (VC)《助视器》.pdf

1、American National Standardfor Ophthalmics Devices for Low VisionANSI Z80.9-2010 (R2015)ANSI Z80.9-2010(R2015)ANSIZ80.9-2010 (R2015)Reaffirmation ofANSI Z80.9-2010American National Standardfor Ophthalmics Devices for Low VisionSecretariatThe Vision CouncilApproved May 13, 2010Reaffirmed May 5, 2015Am

2、erican National Standards 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 ofStan

3、dards Review, substantial 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 the

4、ir resolution.The use 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

5、 American National Standards 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

6、Standards Institute. Requests 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 r

7、equire that action be 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 CouncilZ80

8、 Secretariat225 Reinekers LaneAlexandria, VA 22314Copyright 2010 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 America

9、Developed byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314i Contents Page Foreword . iii 1 Scope . 1 2 Normative references 1 3 Terms and definitions 1 4 Classification 4 5 Requirements . 5 5.1 Optical devices . 5 5.1.1

10、Spatial resolution . 5 5.1.2 Equivalent power - magnifiers 5 5.1.3 Angular Magnification - telescopes 5 5.1.4 Field of view . 5 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.

11、2 Materials and construction . 7 5.2.3 Electrical . 8 6 Environmental conditions of use 8 7 Test methods . 9 7.1 Equivalent power - Magnifiers 9 7.2 Angular magnification - Telescopes . 9 7.3 Display magnification test - electro-optical devices . 9 7.4 Spatial resolution test 9 7.4.1 Optical devices

12、 . 9 7.4.2 Electro-optical devices . 12 7.5 Test for the determination of lateral variation of magnification 13 7.6 Field of view 13 8 Marking, packaging and instructions for use . 13 8.1 Marking . 13 8.2 Documentation 13 Tables 1 Magnifiers/Near telescopes 6 2 Distance telescopes 6 3 Environmental

13、conditions of use . 8 ii Figures 1 Example for an optotype with Ronchi rulings 10 2 Example for a test set-up for near-vision devices 10 3 Example for a test set-up for telescopic systems 11 Annex A Mechanical design 12 iiiForeword (This foreword is not part of American National Standard ANSI Z80.9-

14、2010 (R2015).)This American National Standard specifies optical and mechanical requirements andtest methods as applied to optical and electro-optical devices used by persons withlow vision. With the wide variety of interpretations applied to commonplace terms,such as magnification, it is important t

15、o define terms and outline appropriate use ofterms to reduce confusion.ANSI Z80.9-2010 (R2015) was adapted by a group of experts within the ANSI ASCZ80 Instruments and Low Vision Devices Subcommittee under the chair of William L.Brown, O.D., Ph.D. It is a performance standard. This document is virtu

16、ally identical to ANSI Z80.9-2010. The only changes are minorand editorial. This standard originated in 1998, when the ANSI ASC Z80 Committeeapproved 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 ap-prove

17、d inclusion of ISO 15254, Electro-Optical Devices for Low Vision, into the revi-sion of ANSI Z80.9, thus creating a single standard that includes all classes ofdevices for Low Vision.Suggestions for improvement of this standard are welcome. They should be sent tothe Vision Council, 225 Reinekers Lan

18、e, Suite 700, Alexandria, VA 22314.This standard was 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

19、of this standard, the Z80 Committee consisted of the followingmembers:Thomas C. White, M.D., ChairQuido Cappelli, Vice-ChairWilliam Benjamin, SecretaryJeffrey Endres, SecretariatOrganization Represented Name of RepresentativeAbbott Medical Optics. Leonard BormanAdvance Medical Technologies Associati

20、on Michael PflegerAmerican Academy of Ophthalmology . Thomas WhiteAmerican Academy of Optometry. David LoshinAmerican Ceramic Society . Lyle RubinAmerican Glaucoma Society Steven GeddeAmerican Optometric Association Karl CitekAmerican Society of Cataract and Refractive Ophthalmology Stephen KlyceCon

21、tact Lens Institute. Stan RogaskiContact Lens Manufacturers Association . Quido CapelliDepartment of Veterans Affairs John TownsendFederated Cornea Societies/ASCRS . Michael BelinFood and Drug Administration CDRH/Division of Federal Agencies . Don CalogeroNational Association of Optometrists Avert =

22、 linear expansion of field of view in vertical direction, measured in mm. The procedure is subsequently repeated, 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 re

23、ad off the scale, therefore providing the horizontal and vertical expansion of the still resolvable field of view. The observation telescope must not be refocused during this procedure. The following values are obtained: Ahor* = linear expansion of resolvable field of view in horizontal direction (m

24、m); Avert* = linear expansion of resolvable field of view in vertical direction (mm). Instead of performing the test in the vertical direction, where the difficulties can be experienced when measuring the expansion, it is possible to turn the low-vision device about 90. 7.4.1.5.2 For telescopes Afte

25、r exact alignment of the test set-up, the field of view attainable with the respective low-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.

26、The horizontal and vertical expansion of the field of view is determined by reading the 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

27、 measured in mm. This procedure is subsequently repeated, with the optotype only being 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 ve

28、rtical expansion of the still resolvable field of view. 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 test in the verti

29、cal direction where the difficulties can be experienced when measuring the expansion, it is 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

30、 be resolved. 7.4.2 Electro-optical devices The test optotype is placed on the object table 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. ANSI Z80.9-2

31、010 (R2015) 13 7.5 Test for the determination of lateral variation of magnification Magnification is measured as in 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 mov

32、ed toward the edge of the observed field until one of the directions of the Ronchi ruling cannot be identified and a scale measurement is taken. The values read off the scale provide the horizontal and vertical field measurement. 8 Marking, packaging and instructions for use 8.1 Marking Each device

33、shall be clearly marked with at least the following: a) An identification of the device and the manufacturer with model and serial number (where 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 m

34、eet the requirements of this standard and their minimum specifications. The manufacturer shall also state the recommended display size for 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

35、 display magnification. d) The manufacturers declared value for the equivalent power for magnifiers. e) The manufacturers declared value for angular magnification for telescopes. f) The manufacturers stated range of magnification (where applicable). g) The manufacturers declared value for either nom

36、inal magnification or equivalent power for telemicroscopes / near-vision telescopes. h) The manufacturers declared value for the field of view. For devices of variable magnification, field of view at maximum and minimum magnifications with a stationary object (target) shall be declared. i) Additiona

37、l 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 provided giving user instructions in large print. 8.2.2 Instructions for care and maintenance of the device in large print. ANSI Z80.9-2010 (R2015) 14 Annex A (informative) Mechanical design All controls, knobs, buttons or switches must be made easy to distinguish by the use of suitably contrasting colors, and of sufficient size that they are useable by the visually impaired.