ANSI Z80.37-2017 Ophthalmics - Slit-Lamp Microscopes.pdf

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1、American National Standard for Ophthalmics Slit-Lamp Microscopes ANSI Z80.37-2017 ANSI Z80.37-2017ANSI Z80.37-2017 American National Standard for Ophthalmics Slit-Lamp Microscopes Secretariat The Vision Council Approved December 11, 2017 Published January 11, 2018 American National Standards Institu

2、te, Inc.Approval of an American National Standard requires review by ANSI that the requirements for 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 agr

3、eement has been reached by directly and materially affected interests. Substantial agreement means 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

4、 American National Standards is completely voluntary; their existence does not in any respect preclude 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 S

5、tandards Institute does not develop standards and will in no circumstances give an interpretation of 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 Instit

6、ute. Requests for interpretations should be addressed to the secretariat or sponsor whose name appears 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 CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time.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

7、 action be taken periodically to reaffirm, revise, or withdraw this standard. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. American National StandardPublished by The Vision Council 225 Rein

8、ekers Lane Suite 700 Alexandria, VA 22314 Copyright 2018 by The Vision Council 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 De

9、veloped by The Accredited Committee Z80 for Ophthalmic Standards - The Vision Council Z80 Secretariat 225 Reinekers Lane Suite 700 Alexandria, VA 22314i Contents Page Foreword .ii 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 1 4 Requirements. 2 4.1 General 2 4.2 Optical requirements

10、 2 4.3 Construction and function 4 4.3.1 General 4 4.3.2 High eye point eyepiece. 4 4.4 Optical radiation hazard with slit-lamp microscopes 4 5 Accompanying documents. 5 6 Marking 5 Table 1 Requirements for optical properties 3 Figure 1 Explanation of criterion no. 5 4 Annex A Bibliography 6ii Forew

11、ord (This foreword is not part of American National Standard ANSI Z80.37-2017.) This American National Standard specifies requirements and test methods for optical radiation hazards from slit-lamp microscopes. ANSI Z80.37-2017 was adapted by a group of experts within the ANSI ASC Z80 In- struments a

12、nd Low Vision Devices Subcommittee, under the chair of William L. Brown, O.D., Ph.D. It is a performance standard. This document was developed in 2017 after changes were made to ISO 15504-2 Light hazard protection that resulted in recommendations for levels of radiant expo- sure for retinal photoche

13、mical hazard that were unacceptable to the U.S. delegation to the ISO. Since ISO 10936-2. Light hazard from operation microscopes used in oc- ular surgery, refers to ISO 15004-2 for radiation levels, it was decided that an Ameri- can National Standard for slit-lamp microscopes was needed. Suggestion

14、s for improvement of this standard are welcome. They should be sent to the Vision Council, 225 Reinkers Lane, Suite 700, Alexandria, VA 22314. This standard was processed and approved for submittal to ANSI by the Accredited Standards Committee on Ophthalmic Optics, Z80. Committee approval of this st

15、an- dard does not necessarily imply that all committee members voted for its approval. At the time of approval of this standard, the Z80 Committee consisted of the following members: Thomas C. White, M.D., Chair Neil Roche, Vice-Chair William Benjamin, O.D., Secretary Michael Vitale, Secretariat Org

16、anization Represented Name of Representative Advanced Medical Technology Association Michael Pfleger American Academy of Ophthalmology Thomas White American Academy of Optometry. David Loshin American Ceramic Society Lyle Rubin American Glaucoma Society . Steven Gedde American Optometric Association

17、 . Karl Citek American Society of Cataract and Refractive Surgery . Stephen Klyce Contact Lens Institute. Stan Rogaski Contact Lens Manufacturers Association. Martin Dalsing Cornea Society Michael Belin Department of Veterans Affairs . John Townsend Food is the angle at which the same object is seen

18、 without any instrument at a viewing distance of 250 mm. NOTE 2 The magnification of the microscope comprises the magnifications of the complete system. 3.3 high eye point eyepiece eyepiece in which the exit pupil is of sufficient clearance from the eyepiece to allow spectacles to be worn ANSI Z80.2

19、7-2017 2 4 Requirements 4.1 General The slit-lamp microscope shall conform to the requirements specified in ISO 15004-1. The slit-lamp microscope shall conform to the requirements specified in 4.2, 4.3 and 4.4. Compliance with these requirements is verified by type testing. 4.2 Optical requirements

20、The slit-lamp microscope shall conform to the requirements given in Table 1. These requirements shall be verified by use of measuring devices whose measuring errors are smaller than 10 % of the smallest value to be determined. Test results shall be evaluated in accordance with general rules of stati

21、stics. ANSI Z80.37-2017 3 Table 1 Requirements for optical properties No. Criterion Requirement 1 Permissible tolerance of microscope magnification (see 3.2) 5 % 2 Difference in magnification between left and right observation systems 3 % 3 Angular difference in axis between left and right optical s

22、ystems a, bVertically Interpupillary distance between 60 mm and 66 mm 10 Interpupillary distance between 55 mm and 66 mm and 72 mm 15 Horizontally Convergence 45 Divergence 10 4 Shift in the object plane by change in magnification 0.4 mm 5 Focus tolerance for illumination system with respect to the

23、mechanical rotation axis c Axial ca= 0.5 mm Lateral c(a) = 0.35 mm 6 Tolerance for focal planes of left and right observation systems (R, L) including all magnifications with respect to the focus of illumination system (slit image) in any position R, L xd dx = 2 e7 Focus difference between the left

24、and right observation systems (R, L) xd dx = 2 e8 Eyepiece Calibration error of diopter scale 0.25 D at zero on the diopter scale Range for interpupillary distance adjustment 55 mm to 72 mm Adjustment range (minimum) -5.00 D to +5.00 D -4.00 D to +2.00 D for high eye point eyepieces Difference in ax

25、ial positions of the exit pupils between left and right observation systems 1.5 mm 9 Slit image Minimum width 0.2 mm Maximum length 8.0 mm Parallelism of the sides (for a slit image 0.2 mm 8.0 mm) 0.5 oMaximum width Equal to slit width aWith the eyepiece for which the slit-lamp microscope is designe

26、d. bThis requirement does not apply to those slit-lamp microscopes where, due to the design, the mechanical axes of the eyepieces are not parallel to each other. cFor explanation of criterion No. 5, see Figure 1. dDepth of field, expressed in millimeters: = 2 2 10 6 + 1 7 where: N is the numerical a

27、perture; is the total magnification of the microscope (see 3.2); is the reference wavelength in accordance with ISO 7944, expressed in nanometers. ex is a weighting factor. ANSI Z80.27-2017 4 Key (a) = a sin for a rotational angle range up to = 45 OS observation system IS illumination system RC rota

28、tional center of OS and IS a axial focus tolerance Figure 1 Explanation of criterion No. 5 4.3 Construction and function 4.3.1 General The following requirements shall apply: a) the parallel slit edges shall be smooth and free from any imperfections when observed using the highest magnification; b)

29、the slit image shall be evenly illuminated; c) no contrast decrease in the slit image caused by reflections or scattered light shall be observed; d) the brightness and color transmission of the left and right optical systems shall be identical; e) at the highest magnification, the resolving power in

30、 the center of the field shall be at least 1 800 N. Compliance with these requirements is checked by observation. 4.3.2 High eye point eyepiece If the manufacturer states that the eyepiece is a high eye point eyepiece, the distance between the exit pupil of the observation system and the nearest par

31、t of the eyepiece shall be not less than 17 mm. 4.4 Optical radiation hazard with slit-lamp microscopes This subclause replaces IEC 60601-1:2005 + Amd.1:2012, 10.4, 10.5, 10.6, and 10.7. Slit-lamp microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36. It shall f

32、irst be determined if the slit-lamp microscope is classified as a Group 1 or Group 2 instrument in accordance with ANSI Z80.36, Clause 4. The applicable clauses of ANSI Z80.36 for slit-lamp microscopes are listed below. OS (a) RC ANSI Z80.37-2017 5 Values of E measured for the purpose of calculating

33、 values for ANSI Z80.36, 5.4.2.3, 5.4.2.4, 5.5.1.5, and 5.5.2.1 for retinal radiation hazard shall be determined by measuring the spectral irradiance in the focal plane of the slit-lamp microscope and multiplying this value by 1.11. a) for Group 1 slit-lamp microscopes: 1) applicable requirements of

34、 ANSI Z80.36 are 5.1, 5.2, and 5.4; 2) applicable test methods of ANSI Z80.36 are 6.1, 6.2, and 6.4; 3) if status is determined to be Group 1, there are no further requirements; if status is determined not to be Group 1, the additional requirements given in b) are applicable; b) for Group 2 slit-lam

35、p microscopes: 1) applicable requirements of ANSI Z80.36 are 5.1, 5.3, and 5.5; 2) applicable test methods of ANSI Z80.36 are 6.1, 6.2, 6.3, 6.4, and 6.5; 3) ANSI Z80.36, Clause 7, also applies. If the intended use of the slit-lamp microscope includes the use of supplementary 90 D lenses, an arrange

36、ment shall be made for measurement of corneal- and lenticular-related exposure values. The 90 D lens (e.g., Volk lens) shall be at a position 7 mm beyond the focus plane of the slit-lamp microscope (i.e., between the focus plane and the nominal position of the eye) with the maximum illumination fiel

37、d. The exposure measurement is then taken approximately 7 mm beyond the 90 D lens at the position where the illumination field has a minimum size. 5 Accompanying documents The slit-lamp microscope shall be accompanied by documents containing instructions for use. In particular, this information shal

38、l contain: a) the name and address of the manufacturer; b) if appropriate, a statement that the slit-lamp microscope in its original packaging conforms to the transport conditions as specified in ANSI Z80.36; c) any additional documents as specified in IEC 60601-1:2005+ Amd.1:2012, 7.9; d) a referen

39、ce to this American National Standard, ANSI Z80.37, if the manufacturer or supplier claims compliance with it. 6 Marking The slit-lamp microscope shall be permanently marked with at least the following information: a) the name and address of the manufacturer or supplier; b) the name and model of the slit-lamp microscope; c) marking as required by IEC 60601-1:2005 + Amd.1:2012. ANSI Z80.27-2017 6 Annex A (informative) Bibliography 1 ISO 7944, Optics and optical instruments Reference wavelengths