ANSI Z80.38-2017 Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery.pdf

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1、American National Standardfor Ophthalmics Light Hazard from Operation MicroscopesUsed in Ocular SurgeryANSI Z80.38-2017ANSIZ80.38-2017ANSIZ80.38-2017American National Standardfor Ophthalmics Light Hazard from Operation MicroscopesUsed in Ocular SurgerySecretariatThe Vision CouncilApproved July 28, 2

2、017Published September 14, 2017American 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 j

3、udgement of the ANSI Board ofStandards 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 co

4、ncerted effort be madetowards their 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 no

5、t conforming to the standards.The 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

6、the name of the AmericanNational 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 Ameri

7、can National StandardsInstitute require 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 Standard

8、Published byThe Vision Council225 Reinekers LaneSuite 700Alexandria, VA 22314Copyright 2017 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 t

9、he United States of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers LaneSuite 700Alexandria, VA 22314iContentsPageForeword ii1 Scope. 12 Normative references. 13 Terms and definitions. 14 Requirements for optical radiation haza

10、rd . 24.1 General 24.2 Determination of classification group. 24.3 Requirements for Group 1 instruments 24.3.1 General 24.3.2 Emission limits . 24.4 Requirements for Group 2 instruments 24.4.1 General 24.4.2 Emission limits and guideline values . 24.4.3 Retinal protection device 24.4.4 Stability of

11、light intensity. 35 Test methods . 36 Additional information to be supplied by the manufacturerof Group 2 instruments 36.1 Time to reach recommended maximum exposure forphotochemical aphakic weighted retinal radiant exposure - Continuous wave light sources 36.2 Number of pulses to reach recommended

12、maximum exposurefor photochemical aphakic retinal radiant exposure - Pulsed light sources. 37 Marking 3AnnexA Example of information regarding time to reach recommended maximum retinal exposure to be providedto the user during surgery 4iiForeword (This foreword is not part of American National Stand

13、ard ANSI Z80.38-2017.)This American National Standard specifies requirements and test methods for opticalradiation hazards from operation microscopes that are used during ocular surgery.ANSI Z80.36-2017 was adapted by a group of experts within the ANSI ASC Z80 In-struments and Low Vision Devices Sub

14、committee under the chair of William L.Brown, O.D., Ph.D. It is a performance standard. This document was developed in 2016 when changes were made to ISO 15504-2,Light hazard protection, that resulted in recommendations for levels of radiant expo-sure for retinal photochemical hazard that were unacc

15、eptable to the US delegation tothe ISO. Since ISO 10936-2, Light hazard from operation microscopes used in ocularsurgery, refers to ISO 15004-2 for radiation levels, it was decided that an AmericanNational Standard was needed.Suggestions for improvement of this standard are welcome. They should be s

16、ent tothe Vision Council, 225 Reinekers Lane, 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 vote

17、d for its approval. Atthe time of approval of this standard, the Z80 Committee consisted of the followingmembers:Thomas C. White, M.D., Chair Neil Roche, Vice-ChairWilliam Benjamin, O.D., Secretary Michael Vitale, SecretariatOrganization Represented Name of RepresentativeAdvance Medical Technologies

18、 Association Michael PflegerAmerican Academy of Ophthalmology . Thomas WhiteAmerican Academy of Optometry. David LoshinAmerican Ceramic Society . Lyle RubinAmerican Glaucoma Society Steven GeddeAmerican Optometric Association Karl Citek American Society of Cataract and Refractive Surgery . Stephen K

19、lyce Contact Lens Institute. Stan RogaskiContact Lens Manufacturers Association. Martin Dalsing Cornea Society. Michael Belin Department of Veterans Affairs John TownsendFood & Drug Administration CDRH/Division Don Calogero Individual Ralph StoneJohnson & Johnson Vision . Leonard BorrmannNational As

20、sociation of Optometrists & Opticians Nick Mileti Optical Laboratory Association. Steve SutherlinOpticians Association of America. Tom HicksSunglass Association of America . Tibor Gross The Vision Council . Michael VitaleU.S. ISO TC 172/SC7 Michael VitaleiiiThe Subcommittee on Instruments and Low Vi

21、sion Devices, which developed thisAmerican National Standard, had the following members who contributed to this doc-ument:William L. Brown, O.D., Ph.D., ChairCharles Campbell Bruce DrumSharon MillerRobert RosenbergDexiu ShiDavid SlineyThomas WhiteivAMERICAN NATIONAL STANDARD ANSI Z80.38-2017American

22、 National Standard for Ophthalmics Light Hazard from Operation Microscopes Used in Ocular Surgery 1 1 Scope ANSI Z80.38 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery. NOTE General requirements for operation micros

23、copes and test methods for these requirements are specified in ISO 10936-1. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this American National Standard. All standards are subject to revision, and parties to agreeme

24、nts based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited ap

25、plies. For undated references, the latest edition of the referenced document (including any amendments) applies. ANSI Z80.36, Light hazard protection for ophthalmic instruments ISO 10936-1, Optics and optical instruments - Operation microscopes - Part 1: Requirements and test methods 3 Terms and def

26、initions For the purposes of this document, the following terms and definitions apply. 3.1 Group 1 instrument ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfill the requirements of 5.2 in ANSI Z80.36 3.2 Group 2 instrument ophthalmic instrument for whic

27、h a potential light hazard exists and that does not fulfill the requirements of 5.2 in ANSI Z80.36 3.3 retinal protection device mechanism placed in the path of illumination to increase the time to reach the recommended maximum retinal exposure limit ANSI Z80.38-2017 2 4 Requirements for optical rad

28、iation hazard 4.1 General Operation microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36. 4.2 Determination of classification group The operation microscopes shall be classified as Group 1 or Group 2 instruments as defined in clause 4 in ANSI Z80.36. The test m

29、ethods given in clause 5 in ISO 10936-1 shall be used to make this determination. 4.3 Requirements for Group 1 instruments 4.3.1 General The operation microscope shall be tested in accordance with 5.2 in ANSI Z80.36 to determine if it is a Group 1 instrument. If the operation microscope does not ful

30、fill the requirements of 5.2 in ANSI Z80.36 for any limits therein specified, then for those limits the operation microscope is a Group 2 instrument. 4.3.2 Emission limits The operation microscope shall be tested to assess its compliance with the requirements of 5.4.1 in ANSI Z80.36. For those limit

31、s for which the operation microscope fulfills the requirements of 5.4.1, the operation microscope is a Group 1 instrument, and there are no further requirements. 4.4 Requirements for Group 2 instruments 4.4.1 General For radiation limits for which the operation microscope is found to be a Group 2 (s

32、ee 4.3.1), the requirement of 5.3 in ANSI Z80.36 shall apply. Compliance with 5.3 in ANSI Z80.36 shall be verified using test methods referenced in clause 5. 4.4.2 Emission limits and guideline values For those limits for which the operation microscope does not comply with the requirements of 5.4.1

33、in ANSI Z80.36, it shall comply with the requirements of 5.4.2 and 5.4.3 in ANSI Z80.36. Compliance shall be verified using the test methods referenced in clause 5. 4.4.3 Retinal protection device If the time to reach the recommended maximum exposure for photochemical aphakic weighted retinal radian

34、t exposure is 30 min at maximum output, a retinal protection device shall be installed in the coaxial light path and for each auxiliary illuminator in the instrument. When activated, this device shall increase the time to reach the recommended maximum exposure either by a factor of no less than 5 or

35、 to a time 30 min. The status of the protection device, whether activated or inactivated, shall be clearly evident to the user during surgery. ANSI Z80.38-2017 3 4.4.4 Stability of Iight intensity The operation microscope shall be designed to ensure that, when operated at maximum output, differences

36、 in output due to aging, maintenance, servicing, and lamp and component replacements cannot reduce the time and/or number of pulses needed to reach the recommended maximum exposure below the level determined in accordance with 6.5 in ANSI Z80.36. This shall be applicable throughout the lifetime of t

37、he device when maintained in accordance with the manufacturers specifications. Among other methods, this may be achieved by a risk management process. 5 Test methods See 5.3 of ANSI Z80.36. To assess compliance with Group 1 limits expressed in 6.1, 6.2, and 6.4 in ANSI Z80.36, appropriate measuremen

38、t methods as specified in annex D and annex E in ANSI Z80.36 are to be used. For limits that are found to be Group 2, 6.3 and 6.4 in ANSI Z80.36 apply, using appropriate measurement methods as specified in annex D and annex E in ANSI Z80.36, 6.5.1 in ANSI Z80.36, and 6.5.2 in ANSI Z80.36 (if applica

39、ble). For compliance with 6.5.3 and 6.5.4 in ANSI Z80.36, the time reported to reach the recommended maximum exposure shall be calculated using the radiant exposure value 10 J/cm2. NOTE It is assumed that the value of 10 J/cm2is approximately equivalent to actual exposure of 2.2 J/cm2for the patient

40、 under typical surgical conditions of blur and intermittent occlusion of the retinal image during the surgery. 6 Additional information to be supplied by the manufacturer of Group 2 instruments 6.1 Time to reach recommended maximum exposure for photochemical aphakic weighted retinal radiant exposure

41、 Continuous wave light sources For continuous wave light sources that can be varied in intensity, the time needed to reach the recommended maximum exposure in accordance with 6.5.1 in ANSI Z80.36, for the maximum setting and for 50% of the maximum setting shall be indicated in the users manual (see

42、clause 7 in ANSI Z80.36). The time needed to reach these recommended maximum exposure levels shall be provided for both the instance of using the retinal protection device and the instance of not using it. This information shall also be clearly evident to the user during surgery (see clause 7 in ANS

43、I Z80.36). An example of how this information may be provided is given in annex A. 6.2 Number of pulses to reach recommended maximum exposure for photochemical aphakic retinal radiant exposure Pulsed light sources Where applicable, for pulsed light sources that can be varied in intensity, the number

44、 of pulses needed to reach the recommended maximum exposure in accordance with 6.5.2 in ANSI Z80.36, for the maximum setting and 50% of the maximum setting shall be indicated in the users manual (see clause 7 in ANSI Z80.36). The number of pulses needed to reach these recommended maximum exposure le

45、vels shall be provided for both the instance of using the retinal protection device and the instance of not using it. 7 Marking For the marking of operation microscopes, see ISO 10936-1. ANSI Z80.38-2017 4 Annex A (informative) Example of information regarding time to reach recommended maximum retin

46、al exposure to be provided to the user during surgery Table A.1 Time to reach recommended maximum exposure Maximum output min 50% maximum output min Without retinal protection device X Y With retinal protection device Z W NOTE This information can be provided in the form of meaningful symbols. The l

47、ight emitted from this instrument is potentially hazardous. NOTE 1 Exposure times are for cumulative retinal exposure. NOTE 2 Lower intensities increase the time to reach recommended maximum exposure in direct proportion to the decrease in intensities. NOTE 3 Exposure times are given for clear media. Cloudy media and/or blood will increase these times.